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

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

NCT07457541•Tomsk National Research Medical Center of the Russian Academy of Sciences

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Summary

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

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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

Locations (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, Russia

Key Dates

Start Date

February 26, 2026

Primary Completion Date

December 31, 2026

Completion Date

May 31, 2027

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Lung Cancer (Locally Advanced or Metastatic)Pancreas Cancer, MetastaticBreast Cancer (Locally Advanced or Metastatic)Colorectal Cancer (Locally Advanced or Metastatic)

Interventions

[99mTc]Tc-HYNIC-FAPI

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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