Trials / Active Not Recruiting
Active Not RecruitingNCT07457541
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Lung Cancer (Locally Advanced or Metastatic)
- Pancreas Cancer, Metastatic
- Breast Cancer (Locally Advanced or Metastatic)
- Colorectal Cancer (Locally Advanced or Metastatic)
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-02-26
- Primary completion
- 2026-12-31
- Completion
- 2027-05-31
- First posted
- 2026-03-09
- Last updated
- 2026-03-12
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT07457541. Inclusion in this directory is not an endorsement.