A Study to Evaluate the Diagnostic Efficacy of 68Ga- MY6349 PET/CT in Patients With Tumours

January 15, 2025 updated by: Xijing Hospital

68Ga-MY6349 A Clinical Study of the Diagnostic Efficacy of PET/CT for Tumours of Epithelial Origin

This is a study using an autocontrol approach, enrolling 40 patients with tumours of epithelial origin, who underwent 68Ga- MY6349 and 68Ga-PSMA/18F-FDG PET/CT imaging of patients with tumours of epithelial origin to compare the ability to diagnose, stage and monitor recurrence of tumours of epithelial origin using the pathological findings as the gold standard.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

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 Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China
        • 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:

- Age ≥ 18 years; Patients with pathologically confirmed tumour and proposed surgical resection/exploration (including primary or recurrent metastatic tumour); Expected survival > 3 months, as judged by the doctor; Voluntarily sign the informed consent form; willing and able to follow the study protocol

Exclusion Criteria:

- Persons with a known history of hypersensitivity to 68Ga-MY6349 and 68Ga-PSMA or 18F-FDG and their excipients; Those who cannot tolerate intravenous drug delivery methods (e.g., history of needle and blood sickness); Patients who have received anti-tumour therapy before the examination or neoadjuvant chemotherapy/targeted therapy for tumour reduction after the examination and up to the preoperative period; Pregnant and lactating women; Practitioners who need to be exposed to radioactive conditions for a long time; Serious diseases of heart, kidney, lung, vascular, neurological and psychiatric systems, immunodeficiency diseases and hepatitis/cirrhosis; Have participated in other interventional clinical trials within 1 month prior to screening; Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy; Presence of other conditions that, in the opinion of the investigator, make participation in this study unsuitable.

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: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: before-after study in the same patient

This study is planned to include about 40 patients with tumours of epithelial origin who are proposed for benign-malignant diagnosis or initial staging or recurrence monitoring. Screened subjects will undergo 68Ga-MY6349 and 68Ga-PSMA/18F-FDG PET/CT sequentially within 2 weeks, and pathological results will be obtained within 30 days after drug administration. Histopathological findings and imaging results will be used as the gold standard for final diagnosis.

Translated with DeepL.com (free version)
Diagnostic test: 68Ga-MY6349 PET/CT Scan
The imaging agent 68Ga-MY6349 used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is between 5.0 and 8.0; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations. Specification: 185~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor to Background Ratio(TBR)
Time Frame: 1 day from injection of the tracer
TBR=SUVmax/SUVmean
1 day from injection of the tracer
Maximum Standardized uptake value (SUVmax)
Time Frame: 1 day from injection of the tracer
Maximum Standardized uptake value (SUVmax) of 68Ga-MY6349 and 68Ga-PSMA/18F-FDG in the included subjects' primary and/or metastatic lesions.
1 day from injection of the tracer

Collaborators and Investigators

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

Sponsor

Xijing Hospital

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)

October 18, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KY20242273-C-1

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

product manufactured in and exported from the U.S.

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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