PD-L1 Specific [68Ga]Ga-THP-PDL1-3 Probe for PET Imaging in Solid Tumors

NCT06383598 | Completed

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

Brief Summary

To utilize the \[68Ga\]Ga-THP-PDL1-3 molecular probe to non-invasively detect PD-L1 expression in primary and metastatic lesions of patients with solid tumors. Furthermore, to assess the heterogeneity of PD-L1 expression within the same lesion and across different lesions, and to observe changes in PD-L1 expression during the course of treatment. This approach aims to facilitate patient screening, therapeutic monitoring, and early warning of drug resistance and/or recurrence or metastasis in the treatment of solid tumors with high PD-L1 expression, ultimately enabling personalized targeted therapy in oncology.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Safety and Feasibility

  1. Adverse Event Number of participants with tracer-related adverse events. 2. Feasibility of PET/CT Imaging Number of participants in whom evaluable PET/CT images were successfully acquired at prespecified time points, as independently assessed by a senior nuclear medicine physician. Images were considered evaluable if they met diagnostic quality criteria. 3. Quality Control Standards for the Radiotracer Radiochemical purity ≥95% (determined by iTLC); Sterility (tested by the direct inoculation method according to pharmacopoeial standards); Bacterial endotoxins ≤15 EU/mL (as determined by photometry). 4. Radiation Dosimetry Organ-absorbed doses (mGy/MBq) and effective dose (mSv/MBq) calculated from PET/CT data using OLINDA/EXM software based on the MIRD schema. Organs assessed include, but are not limited to, the liver, spleen, kidneys, lungs, heart, bone marrow, and urinary bladder. Safety and feasibility were evaluated by no adverse events after comprehensive indicators.

  1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.

Secondary Outcomes (1)

• Standardized Uptake Value (SUV)

  Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.

Study Arms (1)

[68Ga]Ga-THP-PDL1-3

EXPERIMENTAL

All study participants will be allocated to this arm (single-arm study).Study participants will undergo \[68Ga\]Ga-THP-PDL1-3 PET/CT scans.After the participant rests quietly for 40 minutes or 1 hour, whole-body imaging of the head and torso will be performed using a United Imaging uEXPLORER Whole-Body PET/CT scanner at 1 h, 2 h, and 3 h post-injection. The scan range will cover from the vertex to the upper third of the thighs. Participants who required a dynamic scan underwent a 40-min serial scan after injection of \[68Ga\]Ga-THP-PDL1-3. PET/CT static imaging was performed at 2 h and 3 h after injection.

Drug: 18F-FDG; Drug: [68Ga]Ga-THP-PDL1-3

Interventions

18F-FDG DRUG

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

[68Ga]Ga-THP-PDL1-3

[68Ga]Ga-THP-PDL1-3 DRUG

\[68Ga\]Ga-THP-PDL1-3 is an investigational tracer, and all participants will undergo \[68Ga\]Ga-THP-PDL1-3 scanning.

[68Ga]Ga-THP-PDL1-3

Eligibility Criteria

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

You may qualify if:

• Age 18-70 years, ECOG score 0 or 1;
• Patients with solid tumors;
• Presence of measurable lesions on imaging examinations;
• Expected survival ≥12 weeks.

You may not qualify if:

• Severe hepatic or renal dysfunction;
• Women who are planning pregnancy, pregnant, or breastfeeding;
• Unable to remain in supine position for 30 minutes;
• Refusal to participate in this clinical study;
• Diagnosis of claustrophobia or other psychiatric disorders;
• Other conditions deemed by the investigator as inappropriate for participation in the trial.

Sponsors & Collaborators

• Hua Zhu: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Hua Zhu

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

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: May 31, 2026
• Study Completion: September 24, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data access will be granted through a secure data sharing agreement for a period of 3 years after publication.
• Access Criteria: Applicants must provide a methodologically sound research plan and obtain approval from their institutional ethics committee.

Locations

CN (1)