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Search / Trial NCT06916442

Granzyme B-targeted PET Imaging Monitoring Tumor Responses to Immunotherapy

Launched by ZHONGNAN HOSPITAL · Mar 31, 2025

Trial Information

Current as of June 04, 2025

Not yet recruiting

Keywords

Granzyme B Pet Imaging Immunotherapy Response Diagnostic Efficacy

ClinConnect Summary

This clinical trial is studying a new imaging technique that uses a special marker to help doctors monitor how well immunotherapy is working for patients with advanced solid tumors. Immunotherapy is a type of cancer treatment that helps the body's immune system fight cancer. The trial will compare this new imaging method, which targets a protein called Granzyme B (GZMB), with the current standard imaging technique, 18F-FDG PET/CT. The goal is to see if the GZMB-targeted imaging can provide more accurate information about tumor responses to treatment, which can help doctors make better decisions for patient care.

To participate in this trial, patients need to be between 18 and 90 years old and have a confirmed diagnosis of malignant solid tumors that have not yet been treated. They should also be willing to follow the study's schedule and requirements. However, pregnant or breastfeeding individuals, those with certain allergies, or those who have difficulty undergoing imaging may not be eligible. Participants can expect to undergo imaging tests and follow-ups to help assess the effectiveness of their immunotherapy treatment, contributing to more personalized care in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • 1. Voluntarily participate and sign the written informed consent form.
  • 2. Aged 18 to 90 years (inclusive), regardless of gender.
  • 3. Treatment-naïve patients with pathologically confirmed malignant solid tumors scheduled to receive immunotherapy.
  • 4. Willing and able to adhere to scheduled visits, treatment plans, and laboratory tests.
  • Exclusion Criteria
  • 1. Pregnant or lactating patients.
  • 2. Patients with a known allergy to GZMB-targeted imaging agents or synthetic excipients.
  • 3. Fasting blood glucose level exceeding 11.0 mmol/L prior to 18F-FDG administration.
  • 4. Patients unable to undergo PET/CT imaging (e.g., inability to lie supine, claustrophobia, severe anxiety related to radiation exposure).
  • 5. Patients with poor compliance or other factors deemed by the investigator to preclude participation in the study.

About Zhongnan Hospital

Zhongnan Hospital, affiliated with Wuhan University, is a leading medical institution in China renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on multidisciplinary collaboration, the hospital employs state-of-the-art facilities and a team of highly skilled professionals to conduct rigorous clinical studies aimed at improving patient outcomes. Zhongnan Hospital prioritizes ethical standards and patient safety, ensuring adherence to regulatory requirements while fostering a culture of scientific excellence. As a prominent sponsor of clinical trials, the hospital plays a pivotal role in contributing to the global medical community and enhancing the understanding of various health conditions.

Locations

Wuhan, Hubei, China

Patients applied

0 patients applied

Trial Officials

Yong He, MD, PhD

Principal Investigator

Zhongnan Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported