NCT07457541

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
11mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Feb 2026May 2027

Study Start

First participant enrolled

February 26, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

March 3, 2026

Last Update Submit

March 10, 2026

Conditions

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

Keywords

Metastatic cancerFibroblast Activation Protein[99mTc]Tc-HYNIC-FAPISPECT/CT

Outcome Measures

Primary Outcomes (4)

  • Gamma camera-based whole-body [99mTc]Tc-HYNIC-FAPI uptake value (%).

    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)

    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).

    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).

    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 Outcomes (4)

  • Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal findings).

    2, 4, 6 and 24 hours after injection.

  • Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with abnormal laboratory findings).

    2, 4, 6 and 24 hours after injection.

  • Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with incidence of adverse events).

    2, 4, 6 and 24 hours after injection.

  • Safety attributable to [99mTc]Tc-HYNIC-FAPI injections (Number of Participants with administration of concomitant medication).

    2, 4, 6 and 24 hours after injection.

Study Arms (1)

Metastatic cancer patients

EXPERIMENTAL

Metastatic cancer patients before starting chemotherapy.

Drug: [99mTc]Tc-HYNIC-FAPI

Interventions

[99mTc]Tc-HYNIC-FAPIDRUG

One single intravenous injection of \[99mTc\]Tc-HYNIC-FAPI, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Also known as: Intravenous injection of [99mTc]Tc-HYNIC-FAPI
Metastatic cancer patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, 634045, Russia

Location

MeSH Terms

Conditions

Lung NeoplasmsNeoplasm MetastasisPancreatic NeoplasmsBreast NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Vladimir I Chernov, MD, Prof.

    TomskNRMC Tomsk, Russia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The overall goal is to study the effectiveness of SPECT imaging Using technetium-99m labeled HYNIC-FAPI in metastatic cancer patients. The main objectives of the study: 1. To evaluate the distribution of 99mTc-HYNIC-FAPI in normal tissues and tumors in metastatic cancer patients at different time intervals. 2. To evaluate dosimetry of 99mTc-HYNIC-FAPI based on the pharmacokinetic parameters of the drug after a single intravenous administration. 3. To study the safety of use and tolerability of the drug 99mTc-HYNIC-FAPI after a single intravenous administration in a diagnostic dosage. Additional research tasks: To conduct a comparative analysis of the diagnostic information obtained in the visualization of metastatic cancer by SPECT using 99mTc-HYNIC-FAPI with data obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) research of postoperative material.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

February 26, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 31, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)