NCT06734572

Brief Summary

As a new dual targeting PET radiotracer, 18F-FAPI-Biotin is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 18F-FAPI-Biotin in patients with various types of cancer and compared them with the results of 18F-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 18F-FAPI.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 25, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

November 28, 2024

Last Update Submit

December 13, 2024

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Dosimetry of normal organs and tumors

    The semiquantitative dosimetry will be performed based on PET/CT acquisitions after the first administration of 18F-FAPI-Biotin. The dose delivered to normal organs and tumors will be recorded.

    From right after tracer injection to 120 minutes at post-injection

Secondary Outcomes (1)

  • Incidence of Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

    up to 1 week

Study Arms (1)

dynamic PET scans

EXPERIMENTAL

PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 120 minutes after injection.

Drug: 18F-FAPIBiotin

Interventions

18F-FAPIBiotinDRUG

The dose will be 148-296 MBq given intravenously.

dynamic PET scans

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Various solid tumors with available histopathological findings • Signed informed consent

You may not qualify if:

  • pregnant or lactational women • who suffered from severe hepatic and renal insufficiency

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

Study Officials

  • Weibing Miao, MD

    First Affiliated Hospital of Fujian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao, MD

CONTACT

+86-0591-87981618miaoweibing@126.com

Rong Lin, MD

CONTACT

+86-0591-87981619linrong1214@foxmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2024

First Posted

December 16, 2024

Study Start

June 25, 2024

Primary Completion

October 1, 2025

Study Completion

December 31, 2025

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations

CN(1)