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NCT Number: NCT06520319

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 68Ga-DOTATATE

Primary outcomes

  1. 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.

Secondary outcomes

  1. immunohistochemistry

    Time frame: through study completion, an average of 2 years

    Primary and lymph node metastases were stained with CCK2 immunohistochemistry and scored.

Study contacts

Contact information is provided by the study sponsor or research team.

Weibing Miao

CONTACT

[email protected]

86-0591-87981618

jieling zheng

CONTACT

[email protected]

86-599-87981619

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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