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AzTrials

Lung Cancer (Locally Advanced or Metastatic)Phase 1NCT07457541

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

A Phase 1 study testing [99mTc]Tc-HYNIC-FAPI in people with Lung Cancer (Locally Advanced or Metastatic) and Pancreas Cancer, Metastatic, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
What is being tested?
[99mTc]Tc-HYNIC-FAPI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteRussia
Study dates
26 Feb 2026to 31 May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Tomsk, Tomsk Oblast, 634045

Other trials in Russia

About this study

Official title: 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.

Read the 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.
Being tested
[99mTc]Tc-HYNIC-FAPI
Keywords
Metastatic cancer, Fibroblast Activation Protein, [99mTc]Tc-HYNIC-FAPI, SPECT/CT
Medical subject headings
Lung Neoplasms, Neoplasm Metastasis, Pancreatic Neoplasms, Breast Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [99mTc]Tc-HYNIC-FAPIDrug

    Also called Intravenous injection of [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.

Study groups in NCT07457541
Study groupRoleWhat they receive
Metastatic cancer patientsExperimentalMetastatic cancer patients before starting chemotherapy.
Receives: Drug: [99mTc]Tc-HYNIC-FAPI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2, 4, 6 and 24 hours after injection.

  2. 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.

    Measured: 2, 4 and 6 hours after injection.

  3. 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.

    Measured: 2, 4 and 6 hours after injection.

  4. 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).

    Measured: 2, 4 and 6 hours after injection.

Secondary outcomes (4)

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

    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).

    Measured: 2, 4, 6 and 24 hours after injection.

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

    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).

    Measured: 2, 4, 6 and 24 hours after injection.

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

    The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the rate of adverse events (Number of Participants).

    Measured: 2, 4, 6 and 24 hours after injection.

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

    The safety attributable to [99mTc]Tc-HYNIC-FAPI injections will be evaluated based on the rate of administration of concomitant medication (Number of Participants).

    Measured: 2, 4, 6 and 24 hours after injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start26 Feb 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457541
Sponsor's protocol ID
ORI-16/2
Status last verified
Jun 2026
First submitted
3 Mar 2026
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [99mTc]Tc-HYNIC-FAPI in people with Lung Cancer (Locally Advanced or Metastatic) and Pancreas Cancer, Metastatic, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gamma camera-based whole-body [99mTc]Tc-HYNIC-FAPI uptake value (%). (time frame: 2, 4, 6 and 24 hours after injection.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07457541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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