Head-to-head Study of 68Ga-MGS5 Versus 68Ga-DOTATATE PET/CT in Patients With Medullary Thyroid Carcinoma

NCT06520319 | Recruiting Phase 1

• 1 other identifier: FirstAHFujian-68Ga-MGS5
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Medullary Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• SUVmax and SUVpeak

  Determination of SUVmean and SUVpeak for detected lesions and discernible organs of 68Ga-MGS5 and 68Ga-DOTATATE scan.

  through study completion, an average of 2 years

Secondary Outcomes (1)

• immunohistochemistry

  through study completion, an average of 2 years

Study Arms (1)

Patients will undergo a 68Ga-MGS5 PET/CTF and 68Ga-DOTATATE PET/CT

EXPERIMENTAL

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

Interventions

68Ga-MGS5 DRUG

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

Patients will undergo a 68Ga-MGS5 PET/CTF and 68Ga-DOTATATE PET/CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Officials

• Weibing Miao

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao

CONTACT

86-0591-87981618; miaoweibing@126.com

jieling zheng

CONTACT

86-599-87981619; 775304265@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Nuclear Medicine

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 25, 2024
• Study Start: June 21, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)