An observational study in Gastroenteropancreatic Neuroendocrine Tumors, sponsored by First Affiliated Hospital of Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 30 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by First Affiliated Hospital of Fujian Medical University · Observational
68-Ga-DOTATATE is a radiotracer targeting somatostatin receptors (SSTR). In this study, we investigated the diagnostic efficacy of delayed \^68\^Ga-DOTATATE PET/MR in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and liver metastases, and performed a head-to-head comparison with conventional 68-Ga-DOTATATE PET/CT.
68-Ga-DOTATATE PET/CT has been established as a gold standard for the diagnosis and staging of well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs). However, its limitations in detecting small or low-avidity liver metastases remain a clinical challenge. In this study, we further evaluate the diagnostic performance of delayed \^68\^Ga-DOTATATE positron emission tomography/magnetic resonance (PET/MR) in patients with GEP-NETs and suspected liver metastases, with a direct comparison to conventional 68-Ga-DOTATATE PET/CT.
First Affiliated Hospital of Fujian Medical University is the lead sponsor of 97 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
46 patients (18 males and 28 females; 56.4±12.9 years（30-74 years old）)
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(a)Histologically confirmed well-differentiated GEP-NETs via biopsy or surgical resection in adults aged 18-80 years,(b) confirmed or suspected liver metastases, as determined by previous imaging studies or PET/CT scans,(c) availability of comprehensive surgical reports, pathological findings, comparative data, and clinical follow-up outcomes for analysis,(d) absence of PET/MR contraindications , with voluntary participation and signed informed consent forms adhering to ethical and research guidelines
Exclusion Criteria:
(a) unavailability of surgical, pathological or long-term follow-up data; (b) non-compliance with age eligibility criteria or presence of comorbidities compromising protocol adherence
1. Sensitivity of Delayed ^68^Ga-DOTATATE PET/MR in Detecting Liver Metastases from GEP-NETs Relative to Conventional Imaging
Using contrast-enhanced MRI or CT as the reference standard, validate the true positive detection rate of delayed \^68\^Ga-DOTATATE PET/MR for liver metastases in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Two experienced readers, blinded to the clinical history but not to the imaging modality, independently assessed the PET/MR and PET/CT images. Disagreements were resolved by consensus.
Time frame: Conventional imaging (MRI or CT) was performed within 3 months of the PET studies.
2. Lesion Detection Rate of Delayed ^68^Ga-DOTATATE PET/MR Compared to Conventional PET/CT in Patients with GEP-NETs
Using a composite reference standard including conventional imaging (MRI/CT) and consensus reading, compare the number and characteristics of liver metastases detected by delayed PET/MR versus conventional PET/CT. Two accredited readers evaluated the images in separate sessions. Additional lesions identified only on PET/MR were categorized as high-uptake or non-uptake based on \^68\^Ga-DOTATATE avidity.
Time frame: All PET/CT and PET/MR scans were performed on the same day following a single radiotracer injection.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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First Affiliated Hospital of Fujian Medical University