Molecular Imaging of Fibroblast Activation Protein Expression Using Labeled Technetium-99m HYNIC-FAPI

March 10, 2026 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

SPECT/CT Imaging of Fibroblast Activation Protein Expression Using Labeled Technetium-99m HYNIC-FAPI ([99mTc]Tc- HYNIC-FAPI) in Metastatic Cancer Patients

The study should evaluate the biological distribution of 99mTc-HYNIC-FAPI in metastatic cancer patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective are:

  1. To assess the distribution of [99mTc]Tc- HYNIC-FAPI in normal tissues and tumors at different time intervals.
  2. To evaluate dosimetry of [99mTc]Tc- HYNIC-FAPI.
  3. To study the safety and tolerability of the drug [99mTc]Tc- HYNIC-FAPI after a single injection in a diagnostic dosage.

The secondary objective are:

1. To compare the obtained [99mTc]Tc- HYNIC-FAPI SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in metastatic cancer patients.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
    • Tomsk Oblast
      • Tomsk, Tomsk Oblast, Russia, 634045
        • Tomsk National Research Medical Center of the Russian Academy of Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject is > 18 years of age
  • Clinical and radiological diagnosis of metastatic cancer with histological verification.
  • White blood cell count: > 2.0 x 10^9/L
  • Haemoglobin: > 80 g/L
  • Platelets: > 50.0 x 10^9/L
  • Bilirubin =< 2.0 times Upper Limit of Normal
  • Serum creatinine: Within Normal Limits
  • Blood glucose level not more than 5.9 mmol/L
  • A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
  • Subject is capable to undergo the diagnostic investigations to be performed in the study
  • Informed consent

Exclusion Criteria:

  • Active current autoimmune disease or history of autoimmune disease
  • Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
  • Known HIV positive or chronically active hepatitis B or C
  • Administration of other investigational medicinal product within 30 days of screening
  • Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metastatic cancer patients
Metastatic cancer patients before starting chemotherapy.
Drug: [99mTc]Tc-HYNIC-FAPI
One single intravenous injection of [99mTc]Tc-HYNIC-FAPI, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Other Names:
  • Intravenous injection of [99mTc]Tc-HYNIC-FAPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gamma camera-based whole-body [99mTc]Tc-HYNIC-FAPI uptake value (%).
Time Frame: 2, 4, 6 and 24 hours after injection.
Whole-body [99mTc]Tc-HYNIC-FAPI uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical.
2, 4, 6 and 24 hours after injection.
SPECT/CT-based [99mTc]Tc-HYNIC-FAPI value in tumor lesions (counts and SUV)
Time Frame: 2, 4 and 6 hours after injection.
99mTc]Tc-HYNIC-FAPI uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts and SUV.
2, 4 and 6 hours after injection.
SPECT/CT -based [99mTc]Tc-HYNIC-FAPI background uptake value (counts and SUV).
Time Frame: 2, 4 and 6 hours after injection.
Focal uptake of [99mTc]Tc-HYNIC-FAPI in the regions without pathological findings will be assessed with SPECT/CT and measured in counts and SUV.
2, 4 and 6 hours after injection.
Tumor-to-background ratio (SPECT/CT).
Time Frame: 2, 4 and 6 hours after injection.
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-HYNIC-FAPI uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-HYNIC-FAPI uptake coinciding with the regions without pathological findings (counts).
2, 4 and 6 hours after injection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal findings).
Time Frame: 2, 4, 6 and 24 hours after injection.
The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (Number of Participants with abnormal findings relative to baseline).
2, 4, 6 and 24 hours after injection.
Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal laboratory findings).
Time Frame: 2, 4, 6 and 24 hours after injection.
The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the blood and urine laboratory tests (Number of Participants with abnormal laboratory findings relative to baseline).
2, 4, 6 and 24 hours after injection.
Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with incidence of adverse events).
Time Frame: 2, 4, 6 and 24 hours after injection.
The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the rate of adverse events (Number of Participants).
2, 4, 6 and 24 hours after injection.
Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with administration of concomitant medication).
Time Frame: 2, 4, 6 and 24 hours after injection.
The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the rate of administration of concomitant medication (Number of Participants).
2, 4, 6 and 24 hours after injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Vladimir I Chernov, MD, Prof., TomskNRMC Tomsk, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [99mTc]Tc- HYNIC-FAPI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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