Clinical trial · Interventional
Fluorescence QRH-882260 Peptide Imaging in the Bile Duct
NCT03438435CI-TRIAL-00048581completedPhase 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)
Patients undergoing ERCP procedure with biliary stricture will have epithelial mucosa labeled with QRH-882260 fluorescence peptide that binds to EGFR. A custom mini-cholangioscope will be used to image the luminal surfaces of the biliary duct that are exposed to the fluorescence peptide. The images will be recorded and analyzed for relative fluorescence pattern and intensity and correlated to patient diagnosis and clinical outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QRH-882260 Heptapeptide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QRH-882260 Heptapeptide
- description
- Five mL of reconstituted (with sterile 0.9% NaCl) QRH-882260 Cy-5-labeled heptapeptide
- interventionNames
- Drug: QRH-882260 Heptapeptide
Primary outcomes (1)
- measure
- Treatment-related Adverse Events
- timeFrame
- 30 months
- description
- Number of treatment-related Adverse Events when using fluorescent imaging with QRH during cholangioscopy
Secondary outcomes (1)
- measure
- Evaluation of imaging content based on the clinical diagnosis
- timeFrame
- 30 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Male or female, aged 18 to 65 2. Scheduled for outpatient ERCP 3. Understands English and is interested in participating 4. Provides signed and dated informed consent form 5. Willing to comply with all study procedures and be available for the duration of the study Exclusion Criteria: 1. Sleep apnea or respiratory problems 2. Pregnant or trying to conceive 3. Known allergy or negative reaction to components of the study product(s) 4. On active chemotherapy or radiation treatment 5. Anything that, in the opinion of the investigator, would place the individual at increased risk or preclude the individual's full compliance with or completion of the study
References
Publications (0)
Data not yet available
No reference posted for this study.