18F-FDGNCT06190574
Diagnostic Efficacy and Prognostic Value of 18F-FDG PET/CT (MR) in Pediatric Solid Blastoma
An observational study of 18F-FDG and Neuroblastoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
the primary histologic origin of extracranial solid tumors in children is malignant embryonic cells, including Neuroblastoma (NB) , Hepatoblastoma(HB), and kidney, wilms' tumor(WT). Their main clinical symptoms are large abdominal masses, the most common lymph node metastasis . Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- 18F-FDG, Neuroblastoma, Hepatoblastoma
- What is being tested?
- Telephone follow-up
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Child, Adult
Study population: We reviewed the electronic medical record and imaging data of 47 children who underwent 18F- FDG PET/CT or PET/MR for the diagnosis of suspected NB, HB or WT from Jan 1, 2013, to Aug 30, 2021.
Who may be able to join
- age < 18 years,
- have pathological results or definite clinical diagnosis as the gold standard.
Who cannot join
- had surgery or chemotherapy before imaging,
- accompanying other tumors,
- diabetic patients or patients with fasting blood glucose ≥ 200 mg/dL.
Trial locations and contacts
1 site in 1 country.
About this study
the primary histologic origin of extracranial solid tumors in children is malignant embryonic cells, including Neuroblastoma (NB) , Hepatoblastoma(HB), and kidney, wilms' tumor(WT). Their main clinical symptoms are large abdominal masses, the most common lymph node metastasis . NB accounts for 15% of childhood cancer deaths, but some low-risk NB can disappear on its own. The International Neuroblastoma Risk Group Staging System (INRGSS) was used to determine Risk before NB treatment, whereas the INRGSS was entirely based on the Neuroblastoma diagnosis, illustrating the importance of imaging in the assessment of NB.18F-FDG is the most commonly used agent in PET imaging of tumor. It can reflect the glucose metabolism of tumor and is widely used in the diagnosis, staging, evaluation of curative effect and prognosis prediction of tumor In this study, the investigators retrospectively analyzed 18F-FDG PET/CT or PET/MRI images from patients with NB, HB, and WT. The investigators sought to assess whether these images provide useful information for diagnosis and prognosis.
- Conditions
- 18F-FDG, Neuroblastoma, Hepatoblastoma, Wilms Tumor
- Being tested
- Telephone follow-up
- Medical subject headings
- Neuroblastoma, Hepatoblastoma, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone follow-upOther
Telephone follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
Region of Interest (ROI)
The presence of non-physiological uptake or uptake in a tissue structure can be considered pathological. The lesion intake is higher than the health organization and is classified as clearly positive. The lesion and the surrounding normal tissue ROI, measure the SUV, TLG and MTV.
Measured: up to 2 years
Sensitivity and specificity of diagnosis and staging
Comparison of the high uptake portion of a pet image suspected to be a histiocytoma for consistency with pathological findings, using the pathological section as the gold standard to calculate the sensitivity and specificity of the diagnostic.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start30 Jul 2021
- Primary completion30 Sep 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 18F-FDGStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoli Lan, PhD, Principal investigator, Study Principal Investigator Wuhan Union Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190574
- Sponsor's protocol ID
- XLan-1218
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hu W, Qu B, Song Y, Li M, Qin C, Lan X. Characteristics and prognostic value of pre-treatment 18F-FDG PET in neuroblastoma. Eur J Nucl Med Mol Imaging. 2026 Jun 5. doi: 10.1007/s00259-026-07977-1. Online ahead of print.
PubMed 42246993
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Efficacy and Prognostic Value of 18F-FDG PET/CT (MR) in Pediatric Solid Blastoma
- ClinicalTrials.gov ID
- NCT06190574
- Acronym / sponsor ID
- XLan-1218
- Conditions
- 18F-FDG, Neuroblastoma, Hepatoblastoma, Wilms Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 5 Jan 2024 (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 primary histologic origin of extracranial solid tumors in children is malignant embryonic cells, including Neuroblastoma (NB) , Hepatoblastoma(HB), and kidney, wilms' tumor(WT). Their main clinical symptoms are large abdominal masses, the most common lymph node metastasis . NB accounts for 15% of childhood cancer deaths, but some low-risk NB can disappear on its own. The International Neuroblastoma Risk Group Staging System (INRGSS) was used to determine Risk before NB treatment, whereas the INRGSS was entirely based on the Neuroblastoma diagnosis, illustrating the importance of imaging in the assessment of NB.18F-FDG is the most commonly used agent in PET imaging of tumor. It can reflect the glucose metabolism of tumor and is widely used in the diagnosis, staging, evaluation of curative effect and prognosis prediction of tumor In this study, the investigators retrospectively analyzed 18F-FDG PET/CT or PET/MRI images from patients with NB, HB, and WT. The investigators sought to assess whether these images provide useful information for diagnosis and prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- We reviewed the electronic medical record and imaging data of 47 children who underwent 18F- FDG PET/CT or PET/MR for the diagnosis of suspected NB, HB or WT from Jan 1, 2013, to Aug 30, 2021.
Key inclusion criteria (2 listed)
- age < 18 years,
- have pathological results or definite clinical diagnosis as the gold standard.
Key exclusion criteria (3 listed)
- had surgery or chemotherapy before imaging,
- accompanying other tumors,
- diabetic patients or patients with fasting blood glucose ≥ 200 mg/dL.
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 |
|---|---|---|
| Telephone follow-upTelephone follow-up | Other | – |
Primary outcome
Region of Interest (ROI)
Time frame: up to 2 years
The presence of non-physiological uptake or uptake in a tissue structure can be considered pathological. The lesion intake is higher than the health organization and is classified as clearly positive. The lesion and the surrounding normal tissue ROI, measure the SUV, TLG and MTV.
Sensitivity and specificity of diagnosis and staging
Time frame: up to 2 years
Comparison of the high uptake portion of a pet image suspected to be a histiocytoma for consistency with pathological findings, using the pathological section as the gold standard to calculate the sensitivity and specificity of the diagnostic.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 42246993Hu W, Qu B, Song Y, Li M, Qin C, Lan X. Characteristics and prognostic value of pre-treatment 18F-FDG PET in neuroblastoma. Eur J Nucl Med Mol Imaging. 2026 Jun 5. doi: 10.1007/s00259-026-07977-1. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for 18F-FDG
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Sarcoma, Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
RecruitingPhase 2
18F-Fluciclovine PET/CT in Multiple Myeloma
Multiple Myeloma, Newly Diagnosed Multiple Myeloma (NDMM)
RecruitingObservational study
A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
Prostate Cancer, Breast Cancer
Active, not recruitingPhase 2
Lesion-to-lesion Comparison of 68Ga-HA-DOTATATE, 18F-DOPA, and 18F-FDG PET/CT in the Evaluation of Metastatic Neuroendocrine Tumors
Neuroendocrine Tumors
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. This study is not recruiting at the moment.
Xiaoli Lan, PhD principal investigator
Study Principal Investigator Wuhan Union Hospital, China
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 18F-FDG and Neuroblastoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Region of Interest (ROI) (time frame: up to 2 years). The study lists 2 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 NCT06190574, which also lists 1 linked publication.
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 19 Mar 2024.