⁶⁸Ga-DPA in the Lung Cancer Diagnosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-28

Study Completion Date

2027-09-28

Brief Summary

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In previous studies, we synthesized a PD-L1-targeted molecular probe, ⁶⁸Ga-DPA, and developed a ⁶⁸Ga-DPA injection for clinical research. Preliminary studies demonstrated its favorable safety profile and excellent imaging performance. Leveraging the established strengths of the Department of Nuclear Medicine at Peking Union Medical College Hospital, we now plan to conduct an exploratory PET/CT imaging study in lung cancer patients. This study aims to provide an in vivo, non-invasive, and visualizable technique for detecting PD-L1 expression levels and spatial distribution in tumors. It will further validate the clinical utility of this technology, offering critical diagnostic insights for initial assessment and treatment efficacy evaluation in PD-L1-positive tumor patients undergoing PD-L1-targeted therapies.

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Detailed Description

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Conditions

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Lung Cancers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-DPA PEWT/CT

Group Type EXPERIMENTAL

68Ga-DPA PET/CT

Intervention Type DIAGNOSTIC_TEST

Use 68Ga-DPA PET/CT in the diagnosis of lung cancer

Interventions

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68Ga-DPA PET/CT

Use 68Ga-DPA PET/CT in the diagnosis of lung cancer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years, regardless of gender.
* Patients clinically confirmed or suspected of lung cancer, with pathological specimens obtainable via biopsy or surgery within the recent 2 months.
* At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
* Expected survival \>3 months.

Exclusion Criteria

* Severe hepatic or renal dysfunction (serum creatinine \>3.0 mg/dL or any liver enzyme level ≥5× upper limit of normal).
* Women who are planning pregnancy, pregnant, or breastfeeding.
* Inability to lie supine for 30 minutes.
* Claustrophobia or other psychiatric disorders.
* Intolerance to any clinical procedures in the study.
* Other conditions deemed ineligible by the investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No