Clinical trial · Interventional
First-in-Human Positron Emission Tomography Study Using the 18F-αvβ6-Binding-Peptide
NCT03164486CI-TRIAL-00104196active not recruitingEarly Phase 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)
This clinical trial studies the side effects of 18F-alphavbeta6-binding-peptide and how well it works in imaging patients with primary or cancer that has spread to the breast, colorectal, lung, or pancreatic. Radiotracers, such as 18F-alphavbeta6-binding-peptide, may improve the ability to locate cancer in the body.
Conditions
Conditions (8)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Malignant Neoplasm in the Breast | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Colon | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Lung | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Rectum | — | UNRESOLVED | — |
| Pancreatic Carcinoma | Pancreatic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-αvβ6-BP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-αvβ6-BP
- description
- Patients receive 18F-alphavbeta6-BP IV and then undergo 4 PET scans over 30 minutes each at 30, 60, 120, and 180 minutes post-injection.
- interventionNames
- Drug: 18F-αvβ6-BP
Primary outcomes (1)
- measure
- Assessment of safe administration of 18F-αvβ6-BP
- timeFrame
- Up to 6 months
- description
- Assessed by measures and/or changes in a given vital sign
Secondary outcomes (2)
- measure
- Measurement of 18F-αvβ6-BP accumulation in tumors
- timeFrame
- Up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with primary or metastatic cancer in one or more of the following locations: breast, colorectal, lung, pancreas * Eastern Cooperative Oncology Group (ECOG) performance score of 0-1 * Will sign the Institutional Review Board (IRB)-approved consent form * Able to remain motionless for up to 30-60 minutes per scan Exclusion Criteria: * Creatinine \> 2 x upper limit of normal * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 x upper limit of normal * Life expectancy \< 3 months (mo) * Women who are pregnant or breast-feeding * Patients who cannot undergo PET/compute tomography (CT) scanning * Lack of availability for follow-up assessments * Participation in another clinical trial involving an investigational agent within 4 weeks of enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.