PD-L1 Specific 68Ga-THP-PD-L1-3 Probe for PET Imaging in Solid Tumors

NCT06383598 | Recruiting

• 1 other identifier: 2022KT74-ZY01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to constrcut a noninvasive approach 68Ga-THP-PD-L1-3 PET/CT to detect the PD-L1 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from anti-PD-L1 treatment.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value（SUV）

  The uptake of the tracer （68Ga-THP-PD-L1-3) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.

  2 years

Study Arms (1)

68Ga-THP-PD-L1-3

EXPERIMENTAL

All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-THP-PD-L1-3 PET/CT scans (At the investigator's discretion, a total of no more than 0.5 mg of non-radiolabeled precursor may be considered for injection. To reduce liver and bone marrow uptake). After resting for 40 minutes or 1 hour, participants underwent United Imaging Healthcare total-body PET/CT for whole body scans or a Siemens Biograph m-CT flow PET/CT from the top of the head to the upper third of the thighs.

Drug: 18F-FDG

Interventions

18F-FDG DRUG

All study participants will undergo one 18F-FDG PET/CT scan.

68Ga-THP-PD-L1-3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>18 years old; ECOG 0 or 1;
• Patients with solid tumorsin or suspected tumor lesions;
• life expectancy \>=12 weeks.

You may not qualify if:

• Significant hepatic or renal dysfunction;
• Is pregnant or ready to pregnant;
• Cannot keep their states for half an hour;
• Refusal to join the clinical study;
• Suffering from claustrophobia or other mental diseases;
• Any other situation that researchers think it is not suitable to participate in the experiment

Sponsors & Collaborators

• Hua Zhu: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Hua Zhu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Zhu

CONTACT

010-88196495; zhuhuabch@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CN (1)