Clinical trial NCT05294120: A Study on Radiation Therapy Guided by the Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT) Device in People With Basal Cell Carcinoma
Official title: A Phase II Trial of Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapY: CLARITY
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Basal Cell Carcinoma
Keywords: Radiation Therapy
Reflectance Confocal Microscopy (RCM)/Optical Coherence Tomography (OCT)
20-553
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Physical Sciences Inc.
First posted: 2022-03-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, open-label, single-center, phase II, single-arm clinical trial.
Primary purpose: TREATMENT

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 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:

* 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

Primary outcomes:
measure: histologic tumor response rate
timeFrame: 6 weeks
Secondary outcomes:
measure: frequency and severity of adverse events
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Christopher Barker, MD
role: PRINCIPAL_INVESTIGATOR
References: