Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia
1 other identifier
observational
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 5, 2019
CompletedFirst Submitted
Initial submission to the registry
August 4, 2019
CompletedFirst Posted
Study publicly available on registry
August 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 14, 2023
February 1, 2023
4.7 years
August 4, 2019
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 2 years
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Patients with suspected or confirmed NETs or patients with suspected TIO
You may not qualify if:
- Acute systemic diseases and electrolyte disorders.
- Pregnant or lactating women.
- Participated in other clinical trials within 4 weeks before the start of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China, Hubei Province
Wuhan, Hubei, 430022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoli Lan, PhD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of nuclear medicine
Study Record Dates
First Submitted
August 4, 2019
First Posted
August 6, 2019
Study Start
May 5, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 14, 2023
Record last verified: 2023-02