Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT05294120
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05294120
Study Brief:
Protocol Section:
NCT05294120