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

Last updated: January 15, 2025
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

68Ga-MY6349 PET/CT Scan

Clinical Study ID

NCT06770478
KY20242273-C-1
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years; Patients with pathologically confirmed tumour and proposed surgicalresection/exploration (including primary or recurrent metastatic tumour); Expectedsurvival > 3 months, as judged by the doctor; Voluntarily sign the informed consentform; willing and able to follow the study protocol

Exclusion

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 deliverymethods (e.g., history of needle and blood sickness); Patients who have receivedanti-tumour therapy before the examination or neoadjuvant chemotherapy/targetedtherapy for tumour reduction after the examination and up to the preoperativeperiod; Pregnant and lactating women; Practitioners who need to be exposed toradioactive conditions for a long time; Serious diseases of heart, kidney, lung,vascular, neurological and psychiatric systems, immunodeficiency diseases andhepatitis/cirrhosis; Have participated in other interventional clinical trialswithin 1 month prior to screening; Patients undergoing chemotherapy, immunotherapyor molecular targeted therapy; Presence of other conditions that, in the opinion ofthe investigator, make participation in this study unsuitable.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: 68Ga-MY6349 PET/CT Scan
Phase:
Study Start date:
October 18, 2024
Estimated Completion Date:
July 31, 2027

Connect with a study center

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

    Xi'an, Shaanxi
    China

    Active - Recruiting

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