Neuroblastoma (NB)MIBG & SSTR NBNCT07064746
Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
An observational study of Neuroblastoma (NB), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The goal of this prospective observational study is to evaluate the diagnostic performance of ¹²³I-MIBG SPECT/CT and SSTR PET in Chinese children with suspected or confirmed neuroblastoma (NB). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neuroblastoma (NB)
- What is being tested?
- ¹²³I-MIBG SPECT/CT and SSTR PET
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2022to 10 Jul 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Target population * Consecutively enrolled neuroblastoma (NB) patients aged 0-18 years, of any sex; * Inclusive of all INSS stages Ⅰ-ⅣS and risk groups (low, intermediate, high), covering newly diagnosed, relapsed, and refractory cases; * Pathologically confirmed NB, or highly suspected NB based on characteristic imaging plus elevated urinary VMA/HVA, with at least one measurable lesion on routine CT/MRI; * Primary and metastatic cases (bone, bone marrow, liver, lymph nodes, etc.) at different treatment stages (before treatment, during treatment, follow-up) are allowed to ensure representativeness in age, sex, histology, stage, and metastatic site distribution.
Who may be able to join
- Ages 0-18 years, any sex
- Histologically confirmed or clinically highly suspected neuroblastoma with planned imaging assessment
- At least one measurable lesion on conventional imaging such as CT or MRI
- ECOG performance status 0-2 and an expected survival of ≥3 months
- Hematologic, hepatic, and renal function meeting the following criteria: Hb ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 × ULN, Cr ≤ 1.5 × ULN
- Informed consent signed by the subject or legal guardian
Who cannot join
- Known history of severe allergy to the radioactive isotope or molecular probe components to be used;
- Pregnancy or lactation;
- Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;
- Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection;
- Bone marrow suppression not yet recovered (Hb < 90 g/L, ANC < 1.5 × 10⁹/L, platelets < 100 × 10⁹/L);
- Inability to complete imaging examinations such as PET/CT (e.g., severe claustrophobia, inability to lie supine for ≥ 30 min);
- Any other situation deemed inappropriate for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210000
Ying Zhang, +86 25 5227 1064, njsdyyykyll@163.com
About this study
The goal of this prospective observational study is to evaluate the diagnostic performance of ¹²³I-MIBG SPECT/CT and SSTR PET in Chinese children with suspected or confirmed neuroblastoma (NB). The main questions it aims to answer are:
- What are the sensitivity and specificity of each modality-alone and combined-for initial staging and for detecting relapse or metastasis?
- Can SSTR-targeted PET reliably identify MIBG-negative NB lesions and help select candidates for peptide-receptor radionuclide therapy (PRRT)?
Pediatric patients (≤18 years) undergoing routine evaluation for NB will receive both imaging studies; results will be correlated with histopathology, clinical course, and 24-month follow-up.
Read the detailed description
Neuroblastoma (NB) is the most common extracranial solid tumor in children. More than 50 % of cases occur before the age of two, while diagnoses after 10 years old are rare. NB accounts for approximately 6 - 10 % of pediatric malignancies. Its biological behavior is highly heterogeneous, with diverse molecular features, a high risk of metastasis, and often occult primary sites, making early detection and definitive diagnosis difficult [1-3]. Rapid disease progression further complicates treatment.
In recent years, driven by large international multicenter collaborations, the diagnosis and management of pediatric NB have entered an era of molecular imaging and targeted theranostics. Especially overseas, rapid advances in screening, diagnosis, treatment research, and clinical translation have yielded well-established guidelines and consensus statements, markedly improving the 5-year survival rate [4]. In contrast, research and clinical translation in China lag behind, and understanding of NB biology varies across regions, leading to uneven diagnostic and therapeutic levels without unified protocols. As a result, an increasing number of Chinese patients seek molecular imaging and targeted therapy abroad. Accelerating domestic translation of new NB technologies is thus critical to improving outcomes.
Nuclear medicine imaging (molecular imaging) employs radionuclide-labeled tracers for early lesion detection. For NB, modalities include classic radioiodinated metaiodobenzylguanidine (MIBG) imaging (¹³¹I/¹²³I/¹²⁴I-MIBG, ¹⁸F-MFBG), ¹⁸F-FDG metabolic imaging, somatostatin-receptor (SSTR)-targeted imaging (⁶⁸Ga-DOTA-TATE/TOC/NOC peptides), and ¹⁸F-DOPA imaging. With continual upgrades of SPECT/CT, quantitative SPECT/CT, and PET/CT-MRI, comparative studies on diagnostic accuracy, staging, early detection of relapse/metastasis, radiation safety, and therapy response assessment have flourished. International indications for NB radionuclide imaging include [5-7]: confirmation of suspected NB/pheochromocytoma/ganglioneuroma, disease staging, treatment planning and response evaluation, post-therapy follow-up, and selection for radionuclide therapy.
NB cells overexpress the norepinephrine transporter; hence norepinephrine analogs such as MIBG are ideal imaging (and therapeutic) ligands. Radioiodinated MIBG accumulates in neural-crest-derived tissues and tumors, exhibiting high sensitivity (88-92 %) and specificity (83-92 %) [8]. It distinguishes residual tumor from non-specific findings on anatomic imaging and more accurately evaluates bone marrow metastases than MRI [10, 11]. ¹³¹I-MIBG is widely used therapeutically, and post-therapy ¹³¹I-MIBG scans assess tracer uptake, disease status, and predict response, forming part of theranostic guidelines [8, 9, 12-14]. However, ¹³¹I emits high-energy γ-photons (364 keV) and has a long half-life, resulting in poorer SPECT image quality and lower sensitivity than ¹²³I (159 keV, much shorter half-life). The shorter half-life of ¹²³I permits higher administered activity within the same radiation dose, yielding superior images [15]. Consequently, ¹²³I-MIBG is expected to become the optimal screening tool for selecting patients for ¹³¹I-MIBG therapy. In high-risk NB, ¹²³I-MIBG detects recurrent bone metastases in 94 % of cases versus 43 % for ¹⁸F-FDG PET/CT [9, 10]. MIBG imaging remains the standard for staging and treatment assessment [16-18].
About 10 % of NBs show low or absent MIBG uptake, risking false-negative results. Combining modalities helps overcome this limitation. Somatostatin, a hypothalamic peptide that inhibits pituitary growth hormone and gastrointestinal hormones [19-21], binds receptors found on pancreatic, neuroendocrine, meningeal, and breast tumors [21-24]. High-affinity SSTRs are expressed in 77-89 % of NB cells [25-28]. Numerous ⁶⁸Ga-DOTA peptides target SSTRs, such as ⁶⁸Ga-DOTA-TATE (highest affinity for SSTR2), ⁶⁸Ga-DOTA-TOC (SSTR5), and ⁶⁸Ga-DOTA-NOC (SSTR3 and SSTR5) [29]. Compared with ¹²³/¹³¹I-MIBG, SSTR-PET/CT offers advantages: faster plasma clearance (2 h vs 2 days), same-day injection and imaging, shorter ⁶⁸Ga half-life (68 min vs 13.1 h/8 days), rapid acquisition (20-40 min vs ~1 h), and minimal preparation (no Lugol's solution). One study showed ⁶⁸Ga-DOTA-TOC PET/CT sensitivity of 94.4 %, significantly higher than ¹²³I-MIBG (76.9 %).
Systematic data on MIBG and SSTR imaging in Chinese NB are scarce. Peptide receptor radionuclide therapy (PRRT) with agents like ¹⁷⁷Lu-DOTA-TATE-proven feasible and safe abroad [30, 31]-is attractive, offering outpatient treatment without thyroid blockade, simplifying care for children and families. Small studies have applied PRRT to relapsed pediatric NB [32-35].
Given tumor heterogeneity, different molecular probes deliver complementary diagnostic and therapeutic information. Although combination imaging is well studied internationally, domestic data are lacking. Ethnic and regional factors warrant investigation. This study will employ ¹²³I-MIBG SPECT/CT fusion and SSTR PET/CT or(and) MRI for NB diagnosis, staging, and follow-up, aiming to provide valuable insights for early definitive diagnosis, precise staging, radionuclide-targeted therapy, and response evaluation in Chinese patients. In heterogeneous tumors, multimodal imaging is expected to offer clear advantages for staging, phenotype characterization, prognostication, and treatment planning.
- Conditions
- Neuroblastoma (NB)
- Being tested
- ¹²³I-MIBG SPECT/CT, SSTR PET
- Keywords
- neuroblastoma, SSTR, MIBG, PET
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
¹²³I-MIBG SPECT/CTDiagnostic test
Patients take Lugol's iodine 2 days and on the day of injection for thyroid blockade. ¹²³I-MIBG (3-5 MBq/kg; max 370 MBq) is given IV. Whole-body planar imaging is performed 24 h post-injection, then focused SPECT/CT of any suspicious areas with low-dose CT; children are sedated only if motion control is required.
SSTR PETDiagnostic test
Patients receive an intravenous bolus of 68Ga-DOTA-TATE (1.8-2.2 MBq/kg, max 200 MBq). After a 45-60 min uptake phase, a low-dose whole-body PET/CT or PET/MRI (skull base-mid-thigh) is acquired for ~20 min; MRI or CT provides attenuation correction. Sedation used when required.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Neuroblastoma Imaging Cohort | This cohort includes pediatric patients (≤18 years) with suspected or confirmed neuroblastoma. Interventions include diagnostic imaging with ¹²³I-MIBG SPECT/CT and SSTR PET/CT for staging, therapy planning, and disease monitoring. Receives: Diagnostic Test: ¹²³I-MIBG SPECT/CT; Diagnostic Test: SSTR PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmean
SUVmean is obtained by outlining a 3-D volume-of-interest around the lesion on attenuation-corrected PET images and averaging all voxel values. Standardized uptake values are calculated as voxel activity concentration (kBq/mL) divided by injected activity per body weight (kBq/g).
Measured: baseline and 6 months
SUVmax
SUVmax is obtained by outlining a 3-D volume of interest (VOI) around the lesion on attenuation-corrected PET images; the software reports the single voxel with the highest activity concentration, normalized to injected tracer dose divided by the patient's body weight (MBq/kg).
Measured: Baseline and 6 months
SUVpeak
SUVpeak is obtained by drawing a fixed-size, 1 cm³ spherical volume of interest centered on the hottest voxel within the tumor on attenuation-corrected PET images; the mean activity concentration inside this sphere is normalized to injected dose per body weight to yield SUVpeak, minimizing noise while reflecting maximal metabolic activity.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start10 Jul 2022
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Neuroblastoma (NB)Studies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Guoqiang Shao, Dr, Study chair, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064746
- Sponsor's protocol ID
- KY20220701-01
- Acronym
- MIBG & SSTR NB
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 21 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within 6 months of the end of the trial, trial data are uploaded to http://www.medresman.org.cn/login.aspx
Publications
Menda Y, O'Dorisio MS, Kao S, Khanna G, Michael S, Connolly M, Babich J, O'Dorisio T, Bushnell D, Madsen M. Phase I trial of 90Y-DOTATOC therapy in children and young adults with refractory solid tumors that express somatostatin receptors. J Nucl Med. 2010 Oct;51(10):1524-31. doi: 10.2967/jnumed.110.075226. Epub 2010 Sep 16.
PubMed 20847174Sadowski SM, Neychev V, Millo C, Shih J, Nilubol N, Herscovitch P, Pacak K, Marx SJ, Kebebew E. Prospective Study of 68Ga-DOTATATE Positron Emission Tomography/Computed Tomography for Detecting Gastro-Entero-Pancreatic Neuroendocrine Tumors and Unknown Primary Sites. J Clin Oncol. 2016 Feb 20;34(6):588-96. doi: 10.1200/JCO.2015.64.0987. Epub 2015 Dec 28.
PubMed 26712231Gains JE, Bomanji JB, Fersht NL, Sullivan T, D'Souza D, Sullivan KP, Aldridge M, Waddington W, Gaze MN. 177Lu-DOTATATE molecular radiotherapy for childhood neuroblastoma. J Nucl Med. 2011 Jul;52(7):1041-7. doi: 10.2967/jnumed.110.085100. Epub 2011 Jun 16.
PubMed 21680680Kong G, Hofman MS, Murray WK, Wilson S, Wood P, Downie P, Super L, Hogg A, Eu P, Hicks RJ. Initial Experience With Gallium-68 DOTA-Octreotate PET/CT and Peptide Receptor Radionuclide Therapy for Pediatric Patients With Refractory Metastatic Neuroblastoma. J Pediatr Hematol Oncol. 2016 Mar;38(2):87-96. doi: 10.1097/MPH.0000000000000411.
PubMed 26296147Hofman MS, Lau WF, Hicks RJ. Somatostatin receptor imaging with 68Ga DOTATATE PET/CT: clinical utility, normal patterns, pearls, and pitfalls in interpretation. Radiographics. 2015 Mar-Apr;35(2):500-16. doi: 10.1148/rg.352140164.
PubMed 25763733Georgantzi K, Tsolakis AV, Stridsberg M, Jakobson A, Christofferson R, Janson ET. Differentiated expression of somatostatin receptor subtypes in experimental models and clinical neuroblastoma. Pediatr Blood Cancer. 2011 Apr;56(4):584-9. doi: 10.1002/pbc.22913. Epub 2010 Nov 30.
PubMed 21298743Moertel CL, Reubi JC, Scheithauer BS, Schaid DJ, Kvols LK. Expression of somatostatin receptors in childhood neuroblastoma. Am J Clin Pathol. 1994 Dec;102(6):752-6. doi: 10.1093/ajcp/102.6.752.
PubMed 7801887Albers AR, O'Dorisio MS, Balster DA, Caprara M, Gosh P, Chen F, Hoeger C, Rivier J, Wenger GD, O'Dorisio TM, Qualman SJ. Somatostatin receptor gene expression in neuroblastoma. Regul Pept. 2000 Mar 17;88(1-3):61-73. doi: 10.1016/s0167-0115(99)00121-4.
PubMed 10706954O'Dorisio MS, Chen F, O'Dorisio TM, Wray D, Qualman SJ. Characterization of somatostatin receptors on human neuroblastoma tumors. Cell Growth Differ. 1994 Jan;5(1):1-8.
PubMed 8123588Orlando C, Raggi CC, Bianchi S, Distante V, Simi L, Vezzosi V, Gelmini S, Pinzani P, Smith MC, Buonamano A, Lazzeri E, Pazzagli M, Cataliotti L, Maggi M, Serio M. Measurement of somatostatin receptor subtype 2 mRNA in breast cancer and corresponding normal tissue. Endocr Relat Cancer. 2004 Jun;11(2):323-32. doi: 10.1677/erc.0.0110323.
PubMed 15163307Reubi JC, Maurer R, Klijn JG, Stefanko SZ, Foekens JA, Blaauw G, Blankenstein MA, Lamberts SW. High incidence of somatostatin receptors in human meningiomas: biochemical characterization. J Clin Endocrinol Metab. 1986 Aug;63(2):433-8. doi: 10.1210/jcem-63-2-433.
PubMed 3013920Reubi JC, Maurer R, von Werder K, Torhorst J, Klijn JG, Lamberts SW. Somatostatin receptors in human endocrine tumors. Cancer Res. 1987 Jan 15;47(2):551-8.
PubMed 3024822Lamberts SW, Koper JW, Reubi JC. Potential role of somatostatin analogues in the treatment of cancer. Eur J Clin Invest. 1987 Aug;17(4):281-7. doi: 10.1111/j.1365-2362.1987.tb02188.x. No abstract available.
PubMed 2889601Reichlin S. Somatostatin. N Engl J Med. 1983 Dec 15;309(24):1495-501. doi: 10.1056/NEJM198312153092406. No abstract available.
PubMed 6139753Burgus R, Ling N, Butcher M, Guillemin R. Primary structure of somatostatin, a hypothalamic peptide that inhibits the secretion of pituitary growth hormone. Proc Natl Acad Sci U S A. 1973 Mar;70(3):684-8. doi: 10.1073/pnas.70.3.684.
PubMed 4514982
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Study of [123I]Metaiodobenzylguanidine and Somatostatin Receptor-Targeted Imaging in the Diagnosis and Staging of Neuroblastoma
- ClinicalTrials.gov ID
- NCT07064746
- Acronym / sponsor ID
- MIBG & SSTR NB / KY20220701-01
- Conditions
- Neuroblastoma (NB)
- Keywords
- neuroblastoma, SSTR, MIBG, PET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective observational study is to evaluate the diagnostic performance of ¹²³I-MIBG SPECT/CT and SSTR PET in Chinese children with suspected or confirmed neuroblastoma (NB). The main questions it aims to answer are:
- What are the sensitivity and specificity of each modality-alone and combined-for initial staging and for detecting relapse or metastasis?
- Can SSTR-targeted PET reliably identify MIBG-negative NB lesions and help select candidates for peptide-receptor radionuclide therapy (PRRT)?
Pediatric patients (≤18 years) undergoing routine evaluation for NB will receive both imaging studies; results will be correlated with histopathology, clinical course, and 24-month follow-up.
Detailed description
Neuroblastoma (NB) is the most common extracranial solid tumor in children. More than 50 % of cases occur before the age of two, while diagnoses after 10 years old are rare. NB accounts for approximately 6 - 10 % of pediatric malignancies. Its biological behavior is highly heterogeneous, with diverse molecular features, a high risk of metastasis, and often occult primary sites, making early detection and definitive diagnosis difficult [1-3]. Rapid disease progression further complicates treatment.
In recent years, driven by large international multicenter collaborations, the diagnosis and management of pediatric NB have entered an era of molecular imaging and targeted theranostics. Especially overseas, rapid advances in screening, diagnosis, treatment research, and clinical translation have yielded well-established guidelines and consensus statements, markedly improving the 5-year survival rate [4]. In contrast, research and clinical translation in China lag behind, and understanding of NB biology varies across regions, leading to uneven diagnostic and therapeutic levels without unified protocols. As a result, an increasing number of Chinese patients seek molecular imaging and targeted therapy abroad. Accelerating domestic translation of new NB technologies is thus critical to improving outcomes.
Nuclear medicine imaging (molecular imaging) employs radionuclide-labeled tracers for early lesion detection. For NB, modalities include classic radioiodinated metaiodobenzylguanidine (MIBG) imaging (¹³¹I/¹²³I/¹²⁴I-MIBG, ¹⁸F-MFBG), ¹⁸F-FDG metabolic imaging, somatostatin-receptor (SSTR)-targeted imaging (⁶⁸Ga-DOTA-TATE/TOC/NOC peptides), and ¹⁸F-DOPA imaging. With continual upgrades of SPECT/CT, quantitative SPECT/CT, and PET/CT-MRI, comparative studies on diagnostic accuracy, staging, early detection of relapse/metastasis, radiation safety, and therapy response assessment have flourished. International indications for NB radionuclide imaging include [5-7]: confirmation of suspected NB/pheochromocytoma/ganglioneuroma, disease staging, treatment planning and response evaluation, post-therapy follow-up, and selection for radionuclide therapy.
NB cells overexpress the norepinephrine transporter; hence norepinephrine analogs such as MIBG are ideal imaging (and therapeutic) ligands. Radioiodinated MIBG accumulates in neural-crest-derived tissues and tumors, exhibiting high sensitivity (88-92 %) and specificity (83-92 %) [8]. It distinguishes residual tumor from non-specific findings on anatomic imaging and more accurately evaluates bone marrow metastases than MRI [10, 11]. ¹³¹I-MIBG is widely used therapeutically, and post-therapy ¹³¹I-MIBG scans assess tracer uptake, disease status, and predict response, forming part of theranostic guidelines [8, 9, 12-14]. However, ¹³¹I emits high-energy γ-photons (364 keV) and has a long half-life, resulting in poorer SPECT image quality and lower sensitivity than ¹²³I (159 keV, much shorter half-life). The shorter half-life of ¹²³I permits higher administered activity within the same radiation dose, yielding superior images [15]. Consequently, ¹²³I-MIBG is expected to become the optimal screening tool for selecting patients for ¹³¹I-MIBG therapy. In high-risk NB, ¹²³I-MIBG detects recurrent bone metastases in 94 % of cases versus 43 % for ¹⁸F-FDG PET/CT [9, 10]. MIBG imaging remains the standard for staging and treatment assessment [16-18].
About 10 % of NBs show low or absent MIBG uptake, risking false-negative results. Combining modalities helps overcome this limitation. Somatostatin, a hypothalamic peptide that inhibits pituitary growth hormone and gastrointestinal hormones [19-21], binds receptors found on pancreatic, neuroendocrine, meningeal, and breast tumors [21-24]. High-affinity SSTRs are expressed in 77-89 % of NB cells [25-28]. Numerous ⁶⁸Ga-DOTA peptides target SSTRs, such as ⁶⁸Ga-DOTA-TATE (highest affinity for SSTR2), ⁶⁸Ga-DOTA-TOC (SSTR5), and ⁶⁸Ga-DOTA-NOC (SSTR3 and SSTR5) [29]. Compared with ¹²³/¹³¹I-MIBG, SSTR-PET/CT offers advantages: faster plasma clearance (2 h vs 2 days), same-day injection and imaging, shorter ⁶⁸Ga half-life (68 min vs 13.1 h/8 days), rapid acquisition (20-40 min vs ~1 h), and minimal preparation (no Lugol's solution). One study showed ⁶⁸Ga-DOTA-TOC PET/CT sensitivity of 94.4 %, significantly higher than ¹²³I-MIBG (76.9 %).
Systematic data on MIBG and SSTR imaging in Chinese NB are scarce. Peptide receptor radionuclide therapy (PRRT) with agents like ¹⁷⁷Lu-DOTA-TATE-proven feasible and safe abroad [30, 31]-is attractive, offering outpatient treatment without thyroid blockade, simplifying care for children and families. Small studies have applied PRRT to relapsed pediatric NB [32-35].
Given tumor heterogeneity, different molecular probes deliver complementary diagnostic and therapeutic information. Although combination imaging is well studied internationally, domestic data are lacking. Ethnic and regional factors warrant investigation. This study will employ ¹²³I-MIBG SPECT/CT fusion and SSTR PET/CT or(and) MRI for NB diagnosis, staging, and follow-up, aiming to provide valuable insights for early definitive diagnosis, precise staging, radionuclide-targeted therapy, and response evaluation in Chinese patients. In heterogeneous tumors, multimodal imaging is expected to offer clear advantages for staging, phenotype characterization, prognostication, and treatment planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Neuroblastoma Imaging Cohort | – | Diagnostic Test: ¹²³I-MIBG SPECT/CT, Diagnostic Test: SSTR PETThis cohort includes pediatric patients (≤18 years) with suspected or confirmed neuroblastoma. Interventions include diagnostic imaging with ¹²³I-MIBG SPECT/CT and SSTR PET/CT for staging, therapy planning, and disease monitoring. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Target population * Consecutively enrolled neuroblastoma (NB) patients aged 0-18 years, of any sex; * Inclusive of all INSS stages Ⅰ-ⅣS and risk groups (low, intermediate, high), covering newly diagnosed, relapsed, and refractory cases; * Pathologically confirmed NB, or highly suspected NB based on characteristic imaging plus elevated urinary VMA/HVA, with at least one measurable lesion on routine CT/MRI; * Primary and metastatic cases (bone, bone marrow, liver, lymph nodes, etc.) at different treatment stages (before treatment, during treatment, follow-up) are allowed to ensure representativeness in age, sex, histology, stage, and metastatic site distribution.
Key inclusion criteria (6 listed)
- Ages 0-18 years, any sex
- Histologically confirmed or clinically highly suspected neuroblastoma with planned imaging assessment
- At least one measurable lesion on conventional imaging such as CT or MRI
- ECOG performance status 0-2 and an expected survival of ≥3 months
- Hematologic, hepatic, and renal function meeting the following criteria: Hb ≥ 90 g/L, ANC ≥ 1.5 × 10⁹/L, platelets ≥ 100 × 10⁹/L, ALT/AST ≤ 2.5 × ULN, Cr ≤ 1.5 × ULN
Key exclusion criteria (7 listed)
- Known history of severe allergy to the radioactive isotope or molecular probe components to be used;
- Pregnancy or lactation;
- Receipt of high-dose chemotherapy/radiotherapy, radionuclide therapy, or participation in other interventional clinical trials within the past 4 weeks;
- Severe or uncontrolled cardiac, pulmonary, hepatic, or renal insufficiency, or active severe infection;
- Bone marrow suppression not yet recovered (Hb < 90 g/L, ANC < 1.5 × 10⁹/L, platelets < 100 × 10⁹/L);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ¹²³I-MIBG SPECT/CTPatients take Lugol's iodine 2 days and on the day of injection for thyroid blockade. ¹²³I-MIBG (3-5 MBq/kg; max 370 MBq) is given IV. Whole-body planar imaging is performed 24 h post-injection, then focused SPECT/CT of any suspicious areas with low-dose CT; children are sedated only if motion control is required. | Diagnostic test | Pediatric Neuroblastoma Imaging Cohort |
| SSTR PETPatients receive an intravenous bolus of 68Ga-DOTA-TATE (1.8-2.2 MBq/kg, max 200 MBq). After a 45-60 min uptake phase, a low-dose whole-body PET/CT or PET/MRI (skull base-mid-thigh) is acquired for ~20 min; MRI or CT provides attenuation correction. Sedation used when required. | Diagnostic test | Pediatric Neuroblastoma Imaging Cohort |
Primary outcome
SUVmean
Time frame: baseline and 6 months
SUVmean is obtained by outlining a 3-D volume-of-interest around the lesion on attenuation-corrected PET images and averaging all voxel values. Standardized uptake values are calculated as voxel activity concentration (kBq/mL) divided by injected activity per body weight (kBq/g).
SUVmax
Time frame: Baseline and 6 months
SUVmax is obtained by outlining a 3-D volume of interest (VOI) around the lesion on attenuation-corrected PET images; the software reports the single voxel with the highest activity concentration, normalized to injected tracer dose divided by the patient's body weight (MBq/kg).
SUVpeak
Time frame: baseline and 6 months
SUVpeak is obtained by drawing a fixed-size, 1 cm³ spherical volume of interest centered on the hottest voxel within the tumor on attenuation-corrected PET images; the mean activity concentration inside this sphere is normalized to injected dose per body weight to yield SUVpeak, minimizing noise while reflecting maximal metabolic activity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2025.
- Results publication: PubMed 20847174Menda Y, O'Dorisio MS, Kao S, Khanna G, Michael S, Connolly M, Babich J, O'Dorisio T, Bushnell D, Madsen M. Phase I trial of 90Y-DOTATOC therapy in children and young adults with refractory solid tumors that express somatostatin receptors. J Nucl Med. 2010 Oct;51(10):1524-31. doi: 10.2967/jnumed.110.075226. Epub 2010 Sep 16.
- Results publication: PubMed 26712231Sadowski SM, Neychev V, Millo C, Shih J, Nilubol N, Herscovitch P, Pacak K, Marx SJ, Kebebew E. Prospective Study of 68Ga-DOTATATE Positron Emission Tomography/Computed Tomography for Detecting Gastro-Entero-Pancreatic Neuroendocrine Tumors and Unknown Primary Sites. J Clin Oncol. 2016 Feb 20;34(6):588-96. doi: 10.1200/JCO.2015.64.0987. Epub 2015 Dec 28.
- Results publication: PubMed 21680680Gains JE, Bomanji JB, Fersht NL, Sullivan T, D'Souza D, Sullivan KP, Aldridge M, Waddington W, Gaze MN. 177Lu-DOTATATE molecular radiotherapy for childhood neuroblastoma. J Nucl Med. 2011 Jul;52(7):1041-7. doi: 10.2967/jnumed.110.085100. Epub 2011 Jun 16.
- Results publication: PubMed 26296147Kong G, Hofman MS, Murray WK, Wilson S, Wood P, Downie P, Super L, Hogg A, Eu P, Hicks RJ. Initial Experience With Gallium-68 DOTA-Octreotate PET/CT and Peptide Receptor Radionuclide Therapy for Pediatric Patients With Refractory Metastatic Neuroblastoma. J Pediatr Hematol Oncol. 2016 Mar;38(2):87-96. doi: 10.1097/MPH.0000000000000411.
- Results publication: PubMed 25763733Hofman MS, Lau WF, Hicks RJ. Somatostatin receptor imaging with 68Ga DOTATATE PET/CT: clinical utility, normal patterns, pearls, and pitfalls in interpretation. Radiographics. 2015 Mar-Apr;35(2):500-16. doi: 10.1148/rg.352140164.
- Results publication: PubMed 21298743Georgantzi K, Tsolakis AV, Stridsberg M, Jakobson A, Christofferson R, Janson ET. Differentiated expression of somatostatin receptor subtypes in experimental models and clinical neuroblastoma. Pediatr Blood Cancer. 2011 Apr;56(4):584-9. doi: 10.1002/pbc.22913. Epub 2010 Nov 30.
- Results publication: PubMed 7801887Moertel CL, Reubi JC, Scheithauer BS, Schaid DJ, Kvols LK. Expression of somatostatin receptors in childhood neuroblastoma. Am J Clin Pathol. 1994 Dec;102(6):752-6. doi: 10.1093/ajcp/102.6.752.
- Results publication: PubMed 10706954Albers AR, O'Dorisio MS, Balster DA, Caprara M, Gosh P, Chen F, Hoeger C, Rivier J, Wenger GD, O'Dorisio TM, Qualman SJ. Somatostatin receptor gene expression in neuroblastoma. Regul Pept. 2000 Mar 17;88(1-3):61-73. doi: 10.1016/s0167-0115(99)00121-4.
- Results publication: PubMed 8123588O'Dorisio MS, Chen F, O'Dorisio TM, Wray D, Qualman SJ. Characterization of somatostatin receptors on human neuroblastoma tumors. Cell Growth Differ. 1994 Jan;5(1):1-8.
- Results publication: PubMed 15163307Orlando C, Raggi CC, Bianchi S, Distante V, Simi L, Vezzosi V, Gelmini S, Pinzani P, Smith MC, Buonamano A, Lazzeri E, Pazzagli M, Cataliotti L, Maggi M, Serio M. Measurement of somatostatin receptor subtype 2 mRNA in breast cancer and corresponding normal tissue. Endocr Relat Cancer. 2004 Jun;11(2):323-32. doi: 10.1677/erc.0.0110323.
- Results publication: PubMed 3013920Reubi JC, Maurer R, Klijn JG, Stefanko SZ, Foekens JA, Blaauw G, Blankenstein MA, Lamberts SW. High incidence of somatostatin receptors in human meningiomas: biochemical characterization. J Clin Endocrinol Metab. 1986 Aug;63(2):433-8. doi: 10.1210/jcem-63-2-433.
- Results publication: PubMed 3024822Reubi JC, Maurer R, von Werder K, Torhorst J, Klijn JG, Lamberts SW. Somatostatin receptors in human endocrine tumors. Cancer Res. 1987 Jan 15;47(2):551-8.
- Individual participant dataSharing planned: Yes. Within 6 months of the end of the trial, trial data are uploaded to http://www.medresman.org.cn/login.aspx
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guoqiang Shao, Dr study chair
Nanjing First Hospital, Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroblastoma (NB), run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoqiang Shao, Dr (+86 153 6615 5689, guoqiangshao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmean (time frame: baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07064746, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2025.