NCT06684028

Brief Summary

To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jul 2023

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

July 12, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

January 22, 2025

Status Verified

November 1, 2024

Enrollment Period

2.1 years

First QC Date

November 1, 2024

Last Update Submit

January 18, 2025

Conditions

CancerSolid Malignancies

Keywords

FAPFAPIPETcancer

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues

    CT and PET scans were performed on the patients injected with 68Ga-FAPI-JNU. After image reconstruction and PET/CT image fusion, the biological distribution of 68Ga-FAPI-JNU in the primary tumor, metastatic tumor and various tissues and organs of the patients was evaluated by radioactive uptake value (standardized uptake value, SUV)

    4 hour

Study Arms (1)

68Ga-FAPI-JNU

EXPERIMENTAL

68Ga-FAPI-JNU is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 hour after injection

Drug: 68Ga-FAPI-JNU

Interventions

68Ga-FAPI-JNUDRUG

Patients will receive the novel tracer 68Ga-FAPI-JNU dose of approximately 2-5 mCi per person

68Ga-FAPI-JNU

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
  • Age 18-85 years old, male or female;
  • Clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as CT and MRI;
  • ECOG score is 0-3 points;

You may not qualify if:

  • Patients with a history or allergic constitution to any component of the developer, including alcohol;
  • pregnant or lactating women;
  • Patients with mental illness or related history;
  • Patients who cannot or cannot undergo a PET/CT scan;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

chunjing Yu

CONTACT

15312238622ycj_wxd1978@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 12, 2024

Study Start

July 12, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

January 22, 2025

Record last verified: 2024-11

Locations

CN(1)