Medullary Thyroid Carcinoma
Conditions
Brief 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.
Interventions
DRUG68Ga-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.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUVmax and SUVpeak | through study completion, an average of 2 years | Determination of SUVmean and SUVpeak for detected lesions and discernible organs of 68Ga-MGS5 and 68Ga-DOTATATE scan. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immunohistochemistry | through study completion, an average of 2 years | Primary and lymph node metastases were stained with CCK2 immunohistochemistry and scored. |
Countries
China
Contacts
Primary ContactWeibing Miao
Backup Contactjieling zheng
Outcome results
None listed