18F-grazy-02 PET/CT to monitor immune therapy in cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, translational imaging study combining PET/CT with 18F-grazy-02 to track Granzyme B expression in cancer patients receiving immunotherapy. It includes patients with suspected or confirmed NSCLC or melanoma who are planned for PET/CT for diagnosis or staging. The trial spans Phase 1 and Phase 2 and focuses on safety and the potential value of the imaging approach for monitoring response to immunotherapy. Participants will undergo PET/CT imaging with the radiotracer 18F-grazy-02 while receiving immunotherapy such as checkpoint inhibitors or CAR-T therapy. Key eligibility criteria include age 18-75, ECOG 0-1, and adequate organ function; major exclusions are pregnancy, severe hepatic/renal dysfunction, low white blood cell count, or inability to comply with imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18-75 years old;
2. ECOG score 0 or 1 point;
3. Participants with suspected or confirmed non-small cell lung cancer or melanoma who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.

Exclusion Criteria:

1. Pregnant or nursing;
2. Severe hepatic or renal dysfunction;
3. Low WBC (less than 3 x 10\^9/L);
4. Unable to comply with the PET/CT imaging procedures.

Where it's running

• Peking University Cancer Hospital & Institute
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Linyu Zhang
• Email: zhanglinyu1@pku.edu.cn
• Phone: +86010-82805175

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.