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

NCT ID: NCT06770478

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-18
• Study Completion Date: 2027-07-31

Brief Summary

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.

Conditions

Tumour of Epithelial Origin; 68Ga-MY6349

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

68Ga-MY6349 PET/CT Scan

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Guo Ying Guo

Role: CONTACT

guoying01192022@163.com

0086+15991459177

Facility Contacts

Ying Guo

Role: primary

guoying01192022@163.com

0086+15991459177

Other Identifiers

KY20242273-C-1

Identifier Type: -

Identifier Source: org_study_id