A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT05294120
This study evaluates the effectiveness of radiation therapy guided by RCM/OCT for treating basal cell carcinoma. Eligible participants have biopsy-proven BCC, clinical stage T1 or T2, and meet specific anatomical and health criteria. Interventions include RCM/OCT imaging and subsequent radiation therapy, with participants completing quality of life questionnaires.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
Eligibility Criteria
Inclusion Criteria
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Biopsy proven basal cell carcinoma
°Up to 3 tumors per patient can be treated per protocol synchronously or metachronously
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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.
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≥18 years old
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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)
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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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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