NCT06438250

Brief Summary

68Ga-JH04 is a novel radiotracer targeting fibroblast activation protein (FAP). In this study, we observed the safety, biodistribution, and radiation dosimetry of 68Ga-JH04 in patients with different types of cancer.

Trial Health

57
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 Mar 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

March 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

May 27, 2024

Last Update Submit

November 12, 2024

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • safety and tolerability

    Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

    Up to 1 week

Secondary Outcomes (2)

  • Human biodistribution

    From right after tracer injection to 150 minutes at post-injection

  • Human dosimetry

    From right after tracer injection to 150 minutes at post-injection

Study Arms (1)

dynamic PET scans

EXPERIMENTAL

PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection

Drug: 68Ga-JH04

Interventions

68Ga-JH04DRUG

The dose will be 148-222 MBq given intravenously.

dynamic PET scans

Eligibility Criteria

Age18 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

    The First Affiliated Hospital, Fujian Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao, MD

CONTACT

+86-0591-87981618miaoweibing@126.com

Guochang Wang, PhD

CONTACT

+86-0591-87981619guochang1007@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Drug: 68Ga-JH04
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

May 31, 2024

Study Start

March 1, 2024

Primary Completion

May 1, 2025

Study Completion

December 31, 2025

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)