An observational study in PET / CT, PET / MR and Neuroendocrine Tumors, sponsored by Wuhan Union Hospital, China. Status unknown at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Wuhan Union Hospital, China · Observational
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.
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.
542 studies on the registry are indexed under Neuroendocrine Tumors; 135 are open to participants now.
This study's planned enrollment of 60 is below the median of 130 across 129 observational studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Wuhan Union Hospital, China is the lead sponsor of 229 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: up to 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2019 (actual). Primary completion is estimated for Dec 2023, 55 months after the start.
Of 54 observational studies under Neuroendocrine Tumors, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 239. This study's planned 55 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.