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

July 21, 2024 updated by: Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients will undergo a 68Ga-MGS5 PET/CTF and 68Ga-DOTATATE PET/CT
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.
Other Names:
  • 68Ga-DOTATATE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVmax and SUVpeak
Time Frame: 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.
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunohistochemistry
Time Frame: through study completion, an average of 2 years
Primary and lymph node metastases were stained with CCK2 immunohistochemistry and scored.
through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Investigators

  • Principal Investigator: Weibing Miao, First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 21, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstAHFujian-68Ga-MGS5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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