A Phase 1 interventional study of 68Ga-MGS5 in Medullary Thyroid Carcinoma, sponsored by First Affiliated Hospital of Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by First Affiliated Hospital of Fujian Medical University · Phase 1, Interventional, and Diagnostic
Cholecystokinin-2 (CCK2) receptor is overexpressed in more than 90% of MTC cases, and preclinical studies have shown that 68Ga-MGS5 (targeting CCK2) has good stability in vivo and is promising for diagnosis and staging of MTC. This prospective study will compare the diagnostic effects of 68Ga-MGS5 and 68Ga-DOTATATE on MTC primary foci, lymph node metastasis, and distant metastasis, and explore the effect of 68Ga-MGS5 PET/CT on the clinical staging (TNM staging) of MTC.
This study was planned to enroll 20 patients with suspected MTC and MTC recurrence who attended the First Hospital of Fujian Medical University from June 2023 onwards. Each patient completed PET/CT examination within 1 week, one 68Ga-DOTATATE PET/CT whole-body examination and two 68Ga-MGS5 PET/CT whole-body examinations (1 hour and 2 hours after injection, respectively). CCK2 immunohistochemical staining and expression scoring of primary foci and lymph node metastases were also performed.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 20 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →First Affiliated Hospital of Fujian Medical University is the lead sponsor of 92 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
MTC Patients received 68Ga-DOTATATE PET/CT imaging and a single injection of 68Ga-MGS5 and two PET/CT scans 1 hour and 2 hours after the injection within one week.
Drug: 68Ga-MGS5
Each patient received a single intravenous injection of 68Ga-DOTATATE (2-4 mCi) and underwent PET/CT scanning 40-60 minutes after the injection. Or receive one intravenous injection of 68Ga-MGS5 and undergo two PET/CT scans at 1 and 2 hours post-injection, respectively.
Also known as: 68Ga-DOTATATE
SUVmax and SUVpeak
Determination of SUVmean and SUVpeak for detected lesions and discernible organs of 68Ga-MGS5 and 68Ga-DOTATATE scan.
Time frame: through study completion, an average of 2 years
immunohistochemistry
Primary and lymph node metastases were stained with CCK2 immunohistochemistry and scored.
Time frame: through study completion, an average of 2 years
Plan to share: No
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First Affiliated Hospital of Fujian Medical University