RecruitingNot ApplicableNCT06383598

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

A First-in-human, Non-randomised, Single-arm Pilot and Feasibility Study of [68Ga]Ga-THP-PDL1-3 PET/CT in Patients With Solid Tumors


Sponsor

Hua Zhu

Enrollment

50 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

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

Exclusion Criteria6

  • 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.

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Interventions

DRUG18F-FDG

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

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

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


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT06383598


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