PET / CTNCT04045834
Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia
An observational study of PET / CT and PET / MR, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Neuroendocrine tumors (NETs) are rare neoplasms arising from the diffuse endocrine system and spreading throughout the different organs and tissues of the body. Tumor-induced osteomalacia (TIO) , is a rare, serious paraneoplastic syndrome primarily derived from a benign tumor of mesenchymal tissue. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- PET / CT, PET / MR, Neuroendocrine Tumors
- What is being tested?
- 68Ga-DOTA-TATE PET/MR and PET/CT imaging
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2019to 31 Dec 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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: About 90% of NETs, such as pancreatic endocrine tumors, pheochromocytoma, paraganglioma, gastrointestinal carcinoid, bronchial carcinoid, medullary thyroid carcinoma, small cell lung cancer, pituitary adenoma, some non-NETs (meninga) Tumor, astrocytoma, breast cancer, etc. have high expression of somatostatin receptor (SSTR). TIO tumors are often derived from benign tumors of mesenchymal tissue, mostly located in bone or soft tissue, hiding in location, slow growth, and difficult to be found, making diagnosis difficult. According to reports in the literature, most of these tumors are positive for SSTR expression, and somatostatin receptor PET/CT imaging can locate lesions, which is a good method for screening TIO and has high specificity.
Who may be able to join
- Patients with suspected or confirmed NETs or patients with suspected TIO
Who cannot join
- Acute systemic diseases and electrolyte disorders.
- Pregnant or lactating women.
- Participated in other clinical trials within 4 weeks before the start of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Hubei Province
Wuhan, Hubei, 430022
Xiaoli Lan, +86-13886193262, lxl730724@hotmail.com
About this study
Neuroendocrine tumors (NETs) are rare neoplasms arising from the diffuse endocrine system and spreading throughout the different organs and tissues of the body. Tumor-induced osteomalacia (TIO) , is a rare, serious paraneoplastic syndrome primarily derived from a benign tumor of mesenchymal tissue. NETs and mesenchymal tumors are often insidious and are undetectable by conventional imaging techniques including ultrasound, computed tomography and magnetic resonance, while a permanent cure will rely on exact localization and completely removal of the tumor.
Positron emission tomography (PET) provides a valuable tool for the diagnosis and differential diagnosis, staging, efficacy evaluation and recurrence monitoring of various tumors. NETs and mesenchymal tumors overexpress somatostatin receptors (SSTRs), so molecular imaging using radiolabeled somatostatin analogues may be one of the best ways to detect the occult tumors. Recently, somatostatin analogue labelled with gallium-68 (68Ga-DOTA-TATE) as a novel positron tracer has shown to be effective for the detection of NETs and mesenchymal tumors. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR，and PET / CT with specific imaging agent 68Ga-DOTA-TATE and conventional imaging agent [F-18]fluorodeoxyglucose to image patients suspected or confirmed NETs and TIO, the aim is to explore the value of hybrid PET/MR and PET/CT in neuroendocrine diseases and TIO.
Read the detailed description
Neuroendocrine tumors (NETs) are rare neoplasms arising from the diffuse endocrine system and spreading throughout the different organs and tissues of the body. Tumor-induced osteomalacia (TIO), is a rare, serious paraneoplastic syndrome primarily derived from a benign tumor of mesenchymal tissue. NETs and mesenchymal tumors are often insidious and are undetectable by conventional imaging techniques including ultrasound, computed tomography and magnetic resonance, while a permanent cure will rely on exact localization and completely removal of the tumor.
Positron emission tomography (PET) provides a valuable tool for the diagnosis and differential diagnosis, staging, efficacy evaluation and recurrence monitoring of various tumors. NETs and mesenchymal tumors overexpress somatostatin receptors (SSTRs), so molecular imaging using radiolabeled somatostatin analogues may be one of the best ways to detect the occult tumors. Recently, somatostatin analogue labelled with gallium-68 (68Ga-DOTA-TATE) as a novel positron tracer has shown to be effective for the detection of NETs and mesenchymal tumors. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR，and PET / CT with specific imaging agent 68Ga-DOTA-TATE and conventional imaging agent [F-18] fluorodeoxyglucose to image patients. For patients suspected of or diagnosed with NETs and TIO, the investigators aim to evaluate the roles of integrated PET/MR and PET/CT in differential diagnosis, detecting primary and metastatic lesions, guilding biopsy, staging and determining treatment plan prior to treatment; for patients with a history of NETs and TIO, the aim is to evaluate the value of integrated PET/MR and PET/CT for treatment response assessment, detection of recurrences and metastatic lesions; for patients with inoperable and metastatic NETs, the aim is to find the value of integrated PET/MR and PET/CT in assessing the expression level of SSTRs to guide peptide receptor radionuclide therapy.
- Conditions
- PET / CT, PET / MR, Neuroendocrine Tumors, Osteomalacia
- Being tested
- 68Ga-DOTA-TATE PET/MR and PET/CT imaging
- Medical subject headings
- Neuroendocrine Tumors, Osteomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-TATE PET/MR and PET/CT imagingDevice
Intravenous access is established in advance, intravenous bolus injection, 68Ga-DOTA-TATE dose is about 2 MBq/kg body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi), 18F-FDG dose is about 3.7-5.4 MBq/kg (0.1 -0.15 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of diagnosis and staging
The presence of non-physiological uptake or uptake in a tissue structure can be considered pathological. The signal intensity of PET indicates the presence and density of SSTR in the tissue. The lesion intake is higher than the liver and is classified as clearly positive. The lesion and the surrounding normal tissue ROI, measure the SUV, and calculate the T/B ratio. Special attention should be paid to the analysis of the causes of false positives and false negative results.
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 posted6 Aug 2019
- Study start5 May 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET / CTStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Lan, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Xiaoli Lan, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045834
- Sponsor's protocol ID
- XLan-S1002
- Status last verified
- Feb 2023
- First submitted
- 4 Aug 2019
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia
- ClinicalTrials.gov ID
- NCT04045834
- Acronym / sponsor ID
- XLan-S1002
- Conditions
- PET / CT, PET / MR, Neuroendocrine Tumors, Osteomalacia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Aug 2019 (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.
Neuroendocrine tumors (NETs) are rare neoplasms arising from the diffuse endocrine system and spreading throughout the different organs and tissues of the body. Tumor-induced osteomalacia (TIO) , is a rare, serious paraneoplastic syndrome primarily derived from a benign tumor of mesenchymal tissue. NETs and mesenchymal tumors are often insidious and are undetectable by conventional imaging techniques including ultrasound, computed tomography and magnetic resonance, while a permanent cure will rely on exact localization and completely removal of the tumor.
Positron emission tomography (PET) provides a valuable tool for the diagnosis and differential diagnosis, staging, efficacy evaluation and recurrence monitoring of various tumors. NETs and mesenchymal tumors overexpress somatostatin receptors (SSTRs), so molecular imaging using radiolabeled somatostatin analogues may be one of the best ways to detect the occult tumors. Recently, somatostatin analogue labelled with gallium-68 (68Ga-DOTA-TATE) as a novel positron tracer has shown to be effective for the detection of NETs and mesenchymal tumors. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR，and PET / CT with specific imaging agent 68Ga-DOTA-TATE and conventional imaging agent [F-18]fluorodeoxyglucose to image patients suspected or confirmed NETs and TIO, the aim is to explore the value of hybrid PET/MR and PET/CT in neuroendocrine diseases and TIO.
Detailed description
Neuroendocrine tumors (NETs) are rare neoplasms arising from the diffuse endocrine system and spreading throughout the different organs and tissues of the body. Tumor-induced osteomalacia (TIO), is a rare, serious paraneoplastic syndrome primarily derived from a benign tumor of mesenchymal tissue. NETs and mesenchymal tumors are often insidious and are undetectable by conventional imaging techniques including ultrasound, computed tomography and magnetic resonance, while a permanent cure will rely on exact localization and completely removal of the tumor.
Positron emission tomography (PET) provides a valuable tool for the diagnosis and differential diagnosis, staging, efficacy evaluation and recurrence monitoring of various tumors. NETs and mesenchymal tumors overexpress somatostatin receptors (SSTRs), so molecular imaging using radiolabeled somatostatin analogues may be one of the best ways to detect the occult tumors. Recently, somatostatin analogue labelled with gallium-68 (68Ga-DOTA-TATE) as a novel positron tracer has shown to be effective for the detection of NETs and mesenchymal tumors. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR，and PET / CT with specific imaging agent 68Ga-DOTA-TATE and conventional imaging agent [F-18] fluorodeoxyglucose to image patients. For patients suspected of or diagnosed with NETs and TIO, the investigators aim to evaluate the roles of integrated PET/MR and PET/CT in differential diagnosis, detecting primary and metastatic lesions, guilding biopsy, staging and determining treatment plan prior to treatment; for patients with a history of NETs and TIO, the aim is to evaluate the value of integrated PET/MR and PET/CT for treatment response assessment, detection of recurrences and metastatic lesions; for patients with inoperable and metastatic NETs, the aim is to find the value of integrated PET/MR and PET/CT in assessing the expression level of SSTRs to guide peptide receptor radionuclide therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- About 90% of NETs, such as pancreatic endocrine tumors, pheochromocytoma, paraganglioma, gastrointestinal carcinoid, bronchial carcinoid, medullary thyroid carcinoma, small cell lung cancer, pituitary adenoma, some non-NETs (meninga) Tumor, astrocytoma, breast cancer, etc. have high expression of somatostatin receptor (SSTR). TIO tumors are often derived from benign tumors of mesenchymal tissue, mostly located in bone or soft tissue, hiding in location, slow growth, and difficult to be found, making diagnosis difficult. According to reports in the literature, most of these tumors are positive for SSTR expression, and somatostatin receptor PET/CT imaging can locate lesions, which is a good method for screening TIO and has high specificity.
Key inclusion criteria (1 listed)
- Patients with suspected or confirmed NETs or patients with suspected TIO
Key exclusion criteria (3 listed)
- Acute systemic diseases and electrolyte disorders.
- Pregnant or lactating women.
- Participated in other clinical trials within 4 weeks before the start of the study.
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 |
|---|---|---|
| 68Ga-DOTA-TATE PET/MR and PET/CT imagingIntravenous access is established in advance, intravenous bolus injection, 68Ga-DOTA-TATE dose is about 2 MBq/kg body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi), 18F-FDG dose is about 3.7-5.4 MBq/kg (0.1 -0.15 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water. | Device | – |
Primary outcome
Sensitivity and specificity of diagnosis and staging
Time frame: up to 2 years
The presence of non-physiological uptake or uptake in a tissue structure can be considered pathological. The signal intensity of PET indicates the presence and density of SSTR in the tissue. The lesion intake is higher than the liver and is classified as clearly positive. The lesion and the surrounding normal tissue ROI, measure the SUV, and calculate the T/B ratio. Special attention should be paid to the analysis of the causes of false positives and false negative results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Xiaoli Lan, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 PET / CT and PET / MR, 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 1 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Lan, PhD (86-027-83692633, lxl730724@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of diagnosis and staging (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.