Clinical trial · Interventional
A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma
A Phase II Trial of Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapY: CLARITY
NCT05294120CI-TRIAL-00108808active not recruitingPhase 2ClinicalTrials.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 purpose of this study is to find out if radiation therapy (RT) guided by the new reflectance confocal microscopy (RCM)/optical coherence tomography (OCT) device is an effective treatment for basal cell carcinoma (BCC). The researchers will also look at the side effects from RT guided by the RCM/OCT device. In addition, will determine the quality of life before and after treatment by having the participant fill out questionnaires.
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 |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy
- description
- If eligible, patients will undergo pretreatment RCM/OCT imaging, followed by RT. Six weeks after the completion of RT, patients will undergo post-treatment assessment with RCM/OCT and biopsy. If residual carcinoma is detected on the biopsy, surgical excision of the BCC will be performed. If no residual carcinoma is detected on the biopsy, the patient will be monitored for clinical evidence of recurrence for up to 3 years.
- interventionNames
- Device: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
- Radiation: Radiation Therapy
Primary outcomes (1)
- measure
- histologic tumor response rate
- timeFrame
- 6 weeks
- description
- The presence of residual carcinoma on a biopsy or surgical excision specimen will be primary determinant for the primary endpoint outcome.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven basal cell carcinoma °Up to 3 tumors per patient can be treated per protocol synchronously or metachronously * Clinical stage T1 or T2 by Union International to Control Cancer 8th edition system * ≤40 mm in maximum dimension * no deep invasion (beyond subcutaneous fat or \>6 mm from granular later of dermis to deepest point of carcinoma) * no perineural invasion of nerves ≥0.1 mm diameter or deeper than dermis * no intraneural invasion * no bone erosion, invasion or foraminal transgression NOTE: For the purposes of protocol inclusion, if any of the features mentioned above is not included in the pathology report they will considered absent. * ≥18 years old * Amenable to RCM/OCT and radiation therapy in opinion of investigator * Some anatomic locations may preclude imaging by RCM/OCT may not be amenable to RCM/OCT imaging * Some medical comorbidities may preclude the delivery of radiation therapy (conditions rendering patients hypersensitive to ionizing radiation, or unable to undergo treatment) * Able and willing to complete the Skindex 16 and Skin Cancer Index (must be able to understand English or Spanish) Exclusion Criteria: * Medical contraindication to radiation therapy in the opinion of the investigator * Prior cancer radiotherapy which precludes the ability to safely deliver radiation therapy in the opinion of the investigator * High likelihood of protocol non-compliance in the opinion of the investigator °Patients who demonstrate unwillingness to undergo protocol-defined treatment or follow-up procedures will be ineligible to participate
References
Publications (0)
Data not yet available
No reference posted for this study.