Status:
ACTIVE_NOT_RECRUITING
A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Physical Sciences Inc.
Conditions:
Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05294120
Start Date
March 3 2022
End Date
March 1 2026
Last Update
April 18 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725