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

NCT ID: NCT06520319

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-21

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Medullary Thyroid Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

68Ga-MGS5

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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68Ga-DOTATATE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Weibing Miao, PhD

Director, Department of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weibing Miao

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Locations

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

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weibing Miao

Role: CONTACT

86-0591-87981618

jieling zheng

Role: CONTACT

86-599-87981619

Facility Contacts

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Weibing Miao, MD

Role: primary

+86 591 87981618

Zhenying Chen, MB

Role: backup

+86 591 87981619

Other Identifiers

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FirstAHFujian-68Ga-MGS5

Identifier Type: -

Identifier Source: org_study_id

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