NCT06284070

Brief Summary

Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2024

Longer than P75 for all trials

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 Progress39%
Jan 2024Dec 2029

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

6 years

First QC Date

February 21, 2024

Last Update Submit

February 21, 2024

Conditions

Cancer

Keywords

FAPIcancerFDGPET

Outcome Measures

Primary Outcomes (1)

  • Diagnostic efficacy

    The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 18F-FAPI PET were calculated and compared to evaluate the diagnostic efficacy.

    Completed within half year after end of the study

Secondary Outcomes (1)

  • SUV

    Completed within one week after PET examination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subjects we selected are adults who are not restricted by gender. For details, please refer to the "EligibilityCriteria" colymn.

You may qualify if:

  • Adult patients (≥ 18 years old);
  • Suspected or newly diagnosed malignant tumor patients;
  • Patients who underwent 18F-FDG and 18F-FAPI PET scans within one week;
  • Patients who are able to provide informed consent forms (signed by participants, parents, or legal representatives) and consent forms in accordance with the guidelines of the Clinical Research Ethics Committee.

You may not qualify if:

  • Pregnant women;
  • Scanned images with poor image quality due to factors such as body movement;
  • Patients with mental illness or other unsuitable conditions for examination, poor compliance, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Daping Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

Related Publications (1)

  • Hirmas N, Hamacher R, Sraieb M, Kessler L, Pabst KM, Barbato F, Lanzafame H, Kasper S, Nader M, Kesch C, von Tresckow B, Hautzel H, Aigner C, Glas M, Stuschke M, Kummel S, Harter P, Lugnier C, Uhl W, Hadaschik B, Grunwald V, Siveke JT, Herrmann K, Fendler WP. Diagnostic Accuracy of 68Ga-FAPI Versus 18F-FDG PET in Patients with Various Malignancies. J Nucl Med. 2024 Mar 1;65(3):372-378. doi: 10.2967/jnumed.123.266652. Epub 2024 Feb 8.

    PMID: 38331453RESULT

Related Links

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Xiao Chen, Ph.D

CONTACT

15922970174xiaochen229@foxmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Nuclear Medicine Department

Study Record Dates

First Submitted

February 21, 2024

First Posted

February 28, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)