PD-L1 Targeting Peptide Probe for PET Imaging of Solid Tumor

March 3, 2026 updated by: Hua Zhu, Peking University Cancer Hospital & Institute

PD-L1 Targeting Peptide Probe 68Ga-cPP-BCH for PET Imaging of Solid Tumor

The objective of this study is to construct a noninvasive approach using radiolabbled peptide 68Ga-cPP-BCH PET/CT to detect the PD-L1 expression of tumor lesion in patients with lung cancer, melanoma and other solid tumor to identify patients benefiting from anti-PD-(L)1 treatment.

Study Overview

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with lung cancer, melanoma or other solid tumors scheduled for immunotherapy or combined immunotherapy; underwent PD-L1 IHC examination before therapy

Description

Inclusion Criteria:

  1. Aged 18-75, male and female, with ECOG score of 0 or 1;
  2. Subjects with lung cancer, melanoma, or other solid tumors scheduled for immunotherapy or combined immunotherapy;
  3. underwent PD-L1 IHC examination before therapy;
  4. The expected survival was more than 26 weeks;
  5. Blood routine test, liver and kidney function meet the following standards: blood routine: WBC >= 4.0 x 10^9/L or neutrophil >= 1.5 x 10^9/:, PLT >= 100 x 10^9 / L, Hb >= 90g / L; Pt or APTT <= 1.5 upper limit of normal value; liver and kidney function: total bilirubin <= 1.5 x ULT (upper limit of normal value), ALT / AST <= 2.5 upper limit of normal value or <= 5 x ULT (subject with liver metastasis), ALP <= 2.5 upper limit of normal value (if bone metastasis or liver metastasis exists, ALP <= 4.5 upper limit of normal value); BUN <= 1.5 x ULT, SCR <= 1.5 x ULT;
  6. According to RECIST1.1, there was at least one measurable target lesion;
  7. Understand and sign informed consent voluntarily with good compliance.

Exclusion Criteria:

  1. The function of liver and kidney was seriously abnormal;
  2. Preparation for pregnant, pregnant and lactating women;
  3. Inability to lie flat for half an hour;
  4. Suffering from claustrophobia or other mental disorders;
  5. Other researchers considered it unsuitable to participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients take 68Ga-cPP-BCH PET/CT before and after therapy
Patients take paired baseline 18F-FDG PET/CT and 68Ga-cPP-BCH PET/CT within 1 week; and take 68Ga-cPP-BCH PET/CT after therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MPR
Time Frame: 3-6 months
major pathological response, in the surgical pathology after neo-adjuvant immunotherapy, the proportion of active tumors was less than 10%.
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 3-6 months
Overall Response Rate
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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