An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-… (NCT06759740) | Clinical Trial Compass
WithdrawnNot Applicable
An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-Like Peptide-1 Receptor (GLP1R) Positive Insulinomas
Stopped: The investigator did not plan to carry out this study and voluntarily withdrew it
China0Started 2026-01
Plain-language summary
Traditional imaging techniques for insulinomas have a low detection rate. This study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel GLP1R imaging agent, 68Ga-DOTA-SEMA, in patients with GLP1R-positive insulinomas.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF).
✓. Age ≥ 18 years.
✓. Normal renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min, and estimated glomerular filtration rate (eGFR) \> 80 mL/min/1.73 m²).
✓. Recurrent hypoglycemia with biochemically confirmed endogenous hyperinsulinemic hypoglycemia (at least 3 episodes of biochemically confirmed endogenous hyperinsulinemic hypoglycemia within the past 3 months, each with detailed blood glucose monitoring records and symptom descriptions confirming endogenous hyperinsulinemia as the cause).
✓. Negative for sulfonylurea drugs and insulin autoantibodies.
✓. ECOG performance status ≤ 2, able to tolerate the examination.
✓. All other toxicities must be ≤ NCI-CTCAE v5.0 Grade 0 or 1.
Exclusion criteria
✕. History of allergy or hypersensitivity to the components or excipients of the investigational drug.
✕. Claustrophobia or inability to tolerate imaging procedures for other reasons.
✕. Clinically significant active infection as determined by the investigator.
✕. History or current presence of uncontrolled primary or metastatic brain tumors.
✕
What they're measuring
1
Radiation dose to major organs and tumors
Timeframe: 7 days
Trial details
NCT IDNCT06759740
SponsorThe Affiliated Hospital Of Southwest Medical University