Clinical trial · Interventional
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
NCT07457541CI-TRIAL-00115954active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study should evaluate the biological distribution of 99mTc-HYNIC-FAPI in metastatic cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer (Locally Advanced or Metastatic) | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
| Colorectal Cancer (Locally Advanced or Metastatic) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer (Locally Advanced or Metastatic) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Pancreas Cancer, Metastatic | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [99mTc]Tc-HYNIC-FAPI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metastatic cancer patients
- description
- Metastatic cancer patients before starting chemotherapy.
- interventionNames
- Drug: [99mTc]Tc-HYNIC-FAPI
Primary outcomes (4)
- measure
- Gamma camera-based whole-body [99mTc]Tc-HYNIC-FAPI uptake value (%).
- timeFrame
- 2, 4, 6 and 24 hours after injection.
- description
- 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.
- measure
- SPECT/CT-based [99mTc]Tc-HYNIC-FAPI value in tumor lesions (counts and SUV)
- timeFrame
- 2, 4 and 6 hours after injection.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.