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Trial Title:
Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma
NCT ID:
NCT06520319
Condition:
Medullary Thyroid Carcinoma
Conditions: Official terms:
Carcinoma
Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-MGS5
Description:
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.
Arm group label:
Patients will undergo a 68Ga-MGS5 PET/CTF and 68Ga-DOTATATE PET/CT
Other name:
68Ga-DOTATATE
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients of either gender, aged ≥ 18 years and ≤80 years.
- Patients with pathologic findings confirming the diagnosis of MTC
- Patients with MTC recurrence
- Signed written consent
Exclusion Criteria:
- Pregnant or breastfeeding female patients
- Patients with claustrophobic behavior
- The inability or unwillingness of the research participant, parent or legal
representative to provide written informed consent
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibing Miao, MD
Phone:
+86 591 87981618
Email:
miaoweibing@126.com
Contact backup:
Last name:
Zhenying Chen, MB
Phone:
+86 591 87981619
Email:
714144972@qq.com
Start date:
June 21, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
First Affiliated Hospital of Fujian Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06520319
