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NCT05396781
Acceptability and Performance of a Mobile Optical Biopsy Technology for Gastrointestinal Cancer Screening
Phase 2 trial testing Proflavine in Suspected or Known Squamous Cell Neoplasia in 41 participants. Completed in 20 January 2022.
20 January 2022
Quick facts
| Lead sponsor | Anandasabapathy, Sharmila, M.D. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 41 |
| Start date | 13 January 2022 |
| Primary completion | 20 January 2022 |
| Estimated completion | 20 January 2022 |
| Sites | 2 locations across United States, Brazil |
Drugs / interventions tested
- Proflavine — full drug profile →
- Mobile, Augmented High Resolution Microendoscope
Conditions studied
- Suspected or Known Squamous Cell Neoplasia — all drugs for Suspected or Known Squamous Cell Neoplasia →
- Prior History of Squamous Cell Dysplasia and /or Neoplasia — all drugs for Prior History of Squamous Cell Dysplasia and /or Neoplasia →
Sponsor
Anandasabapathy, Sharmila, M.D. — full company profile →
Who can join
Adults 18 to 64, any sex, with Suspected or Known Squamous Cell Neoplasia or Prior History of Squamous Cell Dysplasia and /or Neoplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators have a current trial in China and the US which provides significant support for the safety, cost-effectiveness, accuracy and efficiency of a high resolution microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve functionality, portability and broader use of this device by non-experts, the investigators recently developed a prototype marHRME platform with an automated, augmented reality (AR)-interpretation that provides an overlaid endoscopic + micro-endoscopic view, facilitating diagnosis and biopsy targeting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05396781
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Proflavine
Trials testing the same drug.
- NCT02714439 — Low-Cost Imaging for Cervical Cancer Prevention in the Texas Lower Rio Grande Valley · EARLY_PHASE1 · terminated
- NCT02206048 — Use of High-Resolution Microendoscopy (HRME) in Patients With Adenocarcinoma In-Situ (AIS) of the Cervix · NA · completed
- NCT02420665 — Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia · EARLY_PHASE1 · completed
- NCT01269190 — Wide-Field and High Resolution In Vivo Imaging in Visualizing Lesions in Patients With Oral Neoplasia Undergoing Surgery · NA · recruiting
Other recruiting trials for Suspected or Known Squamous Cell Neoplasia
Currently open trials in the same condition.
- NCT06435286 — Effectiveness and Performance of an Optical Biopsy Technology for Esophageal Cancer in Brazil and the United States · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05396781 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Anandasabapathy, Sharmila, M.D.
- Last refreshed: 9 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05396781.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing