NCT05506566

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

August 14, 2022

Last Update Submit

September 16, 2023

Conditions

TumorPositron-Emission Tomography

Outcome Measures

Primary Outcomes (7)

  • Human biodistribution

    reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)

    From right after tracer injection to 2-hours post-injection

  • Human dosimetry

    radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the OLINDA software.

    From right after tracer injection to 2-hours post-injection

  • Standard uptake value (SUV)

    Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG

    Up to 2 weeks

  • Lesion numbers

    Determination of lesion numbers of 68Ga-FAP-CHX and 68Ga-FAPI-04 or 18F-FDG

    Up to 2weeks

  • the sensitivity of 68Ga-FAP-CHX PET/CT

    compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-CHX PET/CT was evaluated.

    Up to 2 weeks

  • the specificity of 68Ga-FAP-CHX PET/CT

    compared with pathology or composite imaging, the specificity of 68Ga-FAP-CHX PET/CT was evaluated.

    Up to 2 weeks

  • the accuracy of 68Ga-FAP-CHX PET/CT

    compared with pathology or composite imaging, the accuracy of 68Ga-FAP-CHX PET/CT was evaluated.

    Up to 2 weeks

Secondary Outcomes (2)

  • Count of participants with treatment emergent adverse events

    Up to 3 days

  • Expression ability of 68Ga-FAP-CHX in different types of tumors

    Up to 3 days

Study Arms (2)

Part I: safety, tolerability, biodistribution and dosimetry

EXPERIMENTAL

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

Drug: 68Ga-FAP-CHX

Part II: diagnostic efficacy

EXPERIMENTAL

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).

Drug: 68Ga-FAP-CHX

Interventions

68Ga-FAP-CHXDRUG

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

Part I: safety, tolerability, biodistribution and dosimetry

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

68Ga-FAPIFluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Weibing Miao, MD

    The First Affiliated Hospital, Fujian Medical University

    STUDY CHAIR

Central Study Contacts

Weibing Miao, MD

CONTACT

86-0591-87981618miaoweibing@126.com

Jie Zang, MD

CONTACT

1590149510615901495106@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nuclear Medicine Department

Study Record Dates

First Submitted

August 14, 2022

First Posted

August 18, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)