MedTrace Logo

[68Ga]Ga-GZP PET for Early Response Prediction in Colorectal Cancer During Neoadjuvant Therapy

NCT06982053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-05-21

No results posted yet for this study

Summary

This diagnostic study investigates the value of 68Ga-NOTA-GZP PET imaging in predicting and evaluating immunotherapy response in malignant tumors by enrolling pathologically confirmed patients scheduled for immunotherapy and healthy volunteers. All participants underwent immunohistochemical staining of tumor tissue for immune checkpoint markers (PD-1 or CTLA-4) and granzyme B expression prior to signing informed consent for 68Ga-NOTA-GZP PET imaging. Patients received baseline scans before initial immunotherapy and follow-up scans during treatment cycles 2-4, with clinical monitoring continuing until 6 months post-treatment, while healthy volunteers completed single scans with pharmacokinetic analysis through serial blood/urine sampling. Comprehensive data collection included demographic information, clinical characteristics, immunohistochemistry results, laboratory tests (blood routine, liver/kidney function), PET imaging findings, and other relevant imaging data, with treatment response ultimately assessed according to RECIST 1.1 and iRECIST criteria at the 6-month follow-up endpoint.

Conditions

  • Colorectal Cancer Control and Prevention
  • Colorectal Cancer Recurrent
  • Colorectal Cancer Metastatic
  • Colorectal Cancer Screening

Interventions

DIAGNOSTIC_TEST

Received 68Ga-NOTA-GZP PET scanning

Received twice 68Ga-NOTA-GZP PET scanning before neoadjuvant therapy and radical surgery.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06982053 on ClinicalTrials.gov