CClinicalTrials.gg
Status unknownNCT05485792FAPI-VTCUpdated Aug 3, 2022

18F-FAPI and 18F-FDG PET/CT in Patients With Various Types of Cancer

An interventional study of 18F-FAPI PET/CT and 18F-FDG PET/CT in Cancer, sponsored by Affiliated Cancer Hospital & Institute of Guangzhou Medical University. Status unknown. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-08-03.

Sponsored by Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.

Read the detailed description

Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fibroblast membranes. FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for the visualization of CAFs. CAFs are crucial component of tumor stroma, promote the growth of cancer cells and are associated with poor prognosis. Currently, Gallium 68 (68Ga)-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors, including lung cancer, gastric carcinomas, peritoneal carcinomas. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.

02

Conditions studied

  • Cancer
03

In context

Lead sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University is the lead sponsor of 28 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. adult patients (aged 18 years or order);
  2. patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include CT, MRI and pathology report);
  3. patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans;
  4. patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

Exclusion Criteria:

  1. patients with non-malignant lesions;
  2. patients with pregnancy;
  3. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    18F-FAPI PET/CT

    Each subject undergone both 18F-FDG and 68Ga-FAPI PET/CT scans within 2 week

    Diagnostic Test: 18F-FAPI PET/CT and 18F-FDG PET/CT

Interventions

  • Diagnostic test18F-FAPI PET/CT and 18F-FDG PET/CT

    Each subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week

06

What researchers measure

Primary outcomes

  1. Maximum standardized uptake value (SUVmax)

    The SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT

    Time frame: 30 days

Secondary outcomes

  1. The target-to-background ratio (TBR)

    The target-to-background ratio (TBR) was calculated by dividing the SUVmax of the lesion by the SUVmax of soft tissue background

    Time frame: 30 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05485792
Lead sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Responsible party
Sponsor
First posted
Aug 3, 2022
Start date
Aug 1, 2022 (estimated)
Primary completion
Dec 30, 2022 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Aug 3, 2022

Study contacts

Rusen Zhang, MD
Contact
zhangrusen2015@163.com
0086-13642328295
Linqi Zhang, PhD
Contact
zhanglinqi0909@163.com
0086-18825135918
Rusen Zhang, MD
study director · Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion