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CompletedNCT05515783Updated Oct 16, 2026

68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies

A Phase 1/2 interventional study of 68Ga-FAP-RGD and 68Ga-FAP-RGD in Tumor, sponsored by First Affiliated Hospital of Fujian Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by First Affiliated Hospital of Fujian Medical University · Phase 1/2, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2022, registered Aug 2022).
Updated Oct 16, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

As an new dual targeting PET radiotracer, 68Ga-FAP-RGD is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-RGD in patients with various types of cancer and compared them with the results of 68Ga-FAPI-02 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-RGD.

Read the detailed description

Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. Integrin αvβ3 is restrictedly expressed on angiogenic blood vessels and tumour cells. It plays a key role in angiogenesis for tumour growth and metastasis. RGD peptide can specifically recognise the integrin αvβ3, which serves as targeted molecular for anti-angiogenesis strategies. 68Ga-FAP-RGD is a novel dual targeting tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-RGD, and performed a head-to-head comparison with 68Ga-FAPI-02 or 18F-FDG PET/CT scans in patients with various cancers.

02

Conditions studied

  • Tumor

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03

In context

Neoplasms

9,617 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 70 is above the median of 50 across 7,432 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

First Affiliated Hospital of Fujian Medical University is the lead sponsor of 97 studies on the registry; 55 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pregnant or lactational women
  • who suffered from severe hepatic and renal insufficiency
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Part I: safety, tolerability, biodistribution and dosimetry

    PET imaging will begin at 30s (30s/bed), 15min (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection

    Drug: 68Ga-FAP-RGD

  • Experimental
    Part II: diagnostic efficacy

    Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-RGD and another agent (68Ga-FAPI-02 or 18F-FDG).

    Drug: 68Ga-FAP-RGD

Interventions

  • Drug68Ga-FAP-RGD

    The dose will be 4-7mCi given intravenously.

  • Drug68Ga-FAP-RGD

    68Ga-FAP-CHX, the dose will be 0.05 (mCi / kg) given intravenously at a single time prior to imaging. 68Ga-FAPI-02, the dose will be 1.8 (MBq /kg) given intravenously at a single time prior to imaging; 18F-FDG, the dose will be 3.7 (MBq / kg) given intravenously at a single time prior to imaging.

06

What researchers measure

Primary outcomes

  1. Human biodistribution

    reported as relative uptake values per organ at 30s, 15min, 30min, 60min and 120 min per individual subject and as a mean over all subjects (Part I)

    Time frame: From right after tracer injection to 2-hours post-injection

  2. Human dosimetry

    radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I). Dosimetry will be calculated using the Hybrid-Dosimetry software.

    Time frame: From right after tracer injection to 2-hours post-injection

  3. Standard uptake value (SUV)

    Determination of SUV for detected lesions and discernible organs of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG

    Time frame: Up to 2 weeks

  4. Lesion numbers

    Determination of lesion numbers of 68Ga-FAP-RGD and 68Ga-FAPI-02 or 18F-FDG

    Time frame: Up to 2 weeks

  5. the sensitivity of 68Ga-FAP-RGD PET/CT

    compared with pathology or composite imaging, the sensitivity of 68Ga-FAP-RGD PET/CT was evaluated.

    Time frame: Up to 2 weeks

  6. the specificity of 68Ga-FAP-RGD PET/CT

    compared with pathology or composite imaging, the specificity of 68Ga-FAP-RGD PET/CT was evaluated.

    Time frame: Up to 2 weeks

  7. the accuracy of 68Ga-FAP-RGD PET/CT

    compared with pathology or composite imaging, the accuracy of 68Ga-FAP-RGD PET/CT was evaluated.

    Time frame: Up to 2 weeks

Secondary outcomes

  1. Count of participants with treatment emergent adverse events

    The frequency and severity of treatment emergent adverse events following 68Ga-FAP-RGD injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0

    Time frame: Up to 3 days

07

Study locations

1 site
  • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
    Fuzhou, Fujian, China
08

References and documents

Publications

  • Chen Y, Zheng S, Zang J, Shao Z, Tu D, Liu Q, Chen X, Miao W, Zhang J. [68Ga]Ga-LNC1007 versus 2-[18F]FDG in the evaluation of patients with metastatic differentiated thyroid cancer: a head-to-head comparative study. Eur J Nucl Med Mol Imaging. 2025 Jan;52(2):683-692. doi: 10.1007/s00259-024-06930-4. Epub 2024 Oct 15. PubMed 39404790 ↗
  • Zang J, Lin R, Wen X, Wang C, Zhao T, Jakobsson V, Yang Y, Wu X, Guo Z, Chen X, Zhang J, Miao W. A Head-to-Head Comparison of 68Ga-LNC1007 and 2-18F-FDG/68Ga-FAPI-02 PET/CT in Patients With Various Cancers. Clin Nucl Med. 2023 Oct 1;48(10):861-868. doi: 10.1097/RLU.0000000000004820. Epub 2023 Sep 2. PubMed 37682601 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2022 to primary completion in Sep 2024, 28 months.

Of 120 non-industry phase 1/2 interventional studies under Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 79. This study's 28 months is below that.

Counting every sponsor, half of 417 studies reached it within 59 months; a quarter within 36 and three quarters within 84.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion May 2024 → Sep 2024 and completion May 2024 → Oct 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2022
First posted
Aug 25, 2022
StartActual
May 1, 2022
Primary completionActual
Sep 1, 2024was May 2024
CompletionActual
Oct 1, 2025was May 2024
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Completed
changed Oct 16, 2026
Primary completion
May 1, 2024→Sep 1, 2024 (actual)
Oct 16, 2026
Study completion
May 1, 2024→Oct 1, 2025 (actual)
Oct 16, 2026
Enrollment
50 (estimated)→70 (actual)
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Status unknown→Completed
    Primary completion May 1, 2024→Sep 1, 2024 (now actual)
    Study completion May 1, 2024→Oct 1, 2025 (now actual)
    Enrollment 50 (estimated)→70 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05515783
Lead sponsor
First Affiliated Hospital of Fujian Medical University
Responsible party
Weibing Miao, PhD (Director of Nuclear Medicine Department, First Affiliated Hospital of Fujian Medical University) — Principal investigator
First posted
Aug 25, 2022
Start date
May 1, 2022
Primary completion
Sep 1, 2024
Completion
Oct 1, 2025
Last update
Oct 16, 2026

Study contacts

Weibing Miao, MD
study chair · The First Affiliated Hospital, Fujian Medical University

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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