A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Basal Cell Carcinoma
Спонсор: Memorial Sloan Kettering Cancer Center
Налично на:
БГ
Обобщение
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.
Кой може да участва
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
Интервенции
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided
DEVICE
Radiation Therapy
RADIATION
Места на провеждане
7
САЩ (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)