68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies

NCT05515783

Tumor

UNKNOWN PHASE1/PHASE2

Tracer Targeting FAP PET Imaging in Patients

NCT05691894

Cancer

UNKNOWN EARLY_PHASE1

68Ga-FAPI-RGD PET/CT for Dual Integrin αvβ3 and FAP-targeted Imaging in Patients With Various Types of Cancer and Compared With 18F-FDG

NCT05543317

Tumor, Solid Positron-Emission Tomography

COMPLETED NA

68Ga-JH04 PET/CT in Patients With Various Types of Cancer

NCT06455735

Tumor

RECRUITING EARLY_PHASE1

68Ga-NI-FAPI PET/CT: First-in-human Study

NCT06688305

Malignant Neoplasm

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. 68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a head-to-head comparison with 68Ga-FAPI-04 or 18F-FDG PET/CT scans in patients with various cancers.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tumor Positron-Emission Tomography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part I: safety, tolerability, biodistribution and dosimetry

PET imaging will begin at 30s (30s/bed), 15min (1 min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection, and whole-body low-dose CT needed to be re-acquired at 120 minutes

Group Type EXPERIMENTAL

68Ga-FAP-CHX

Intervention Type DRUG

The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging

Part II: diagnostic efficacy

Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-CHX and another agent (68Ga-FAPI-04 or 18F-FDG).

Group Type EXPERIMENTAL

68Ga-FAP-CHX

Intervention Type DRUG

68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging； 68Ga-FAPI-04, the dose will be 1.8 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging； 18F-FDG, the dose will be 3.7 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging；

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga-FAP-CHX

The dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging

Intervention Type DRUG

68Ga-FAP-CHX

68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) +/- 10% given intravenously at a single time prior to imaging； 68Ga-FAPI-04, the dose will be 1.8 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging； 18F-FDG, the dose will be 3.7 (MBq / kg) +/- 10% given intravenously at a single time prior to imaging；

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

68Ga-FAPI-04 18F-FDG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years \< Age \< 75 years
* Various solid tumors with available histopathological findings, and have not been treated surgically.
* Signed informed consent.

Exclusion Criteria

* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes