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Активно (без набиране) Фаза 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

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)
Uniondale , New York
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
03.03.2022
Крайна дата
01.03.2027
Регистрационен номер
NCT05294120
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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