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Active, Not Recruiting

NCT Number: NCT07457541

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Cancer (Locally Advanced or Metastatic) Breast Cancer (Locally Advanced or Metastatic) Breast Diseases Breast Neoplasms Colonic Diseases Colorectal Cancer (Locally Advanced or Metastatic) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreas Cancer, Metastatic Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, 634045, Russia

About this study

The primary objective are:

  • To assess the distribution of [99mTc]Tc- HYNIC-FAPI in normal tissues and tumors at different time intervals.
  • To evaluate dosimetry of [99mTc]Tc- HYNIC-FAPI.
  • 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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[99mTc]Tc-HYNIC-FAPI

Drug

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

Primary outcomes

  1. 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. 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.

  3. 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.

  4. 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).

Secondary outcomes

  1. 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. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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