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Active (not recruiting) Phase 2 NCT05294120

A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma

Phase 2 – studying effectiveness and dosage
Conditions: Basal Cell Carcinoma

Sponsor: Memorial Sloan Kettering Cancer Center

trial.available_in: БГ
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.
Who can participate
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
Interventions
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
DEVICE
Radiation Therapy
RADIATION
Locations 7
United States (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge , New Jersey
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack , New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison , New York
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown , New Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale , New Jersey
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York , New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale , New York
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
03.03.2022
Completion date
01.03.2027
Registry ID
NCT05294120
Source
clinicaltrials.gov
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