RCM/OCT-Guided Radiation Therapy for Basal Cell Carcinoma

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byChristopher Barker, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new way to use radiation therapy for treating basal cell carcinoma. The treatment uses an advanced imaging device to help doctors target the cancer more accurately. Researchers will also check for side effects and see how the treatment affects patients' quality of life. Electronic brachytherapy (EBT) is an emerging treatment technique for basal cell carcinoma (BCC).

Research Team

Christopher Barker, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with biopsy-proven basal cell carcinoma (BCC) that's not deeply invasive or larger than 40mm. Up to three tumors can be treated, and they mustn't have bone erosion or significant nerve invasion. Participants need to understand English/Spanish for questionnaires and be considered suitable for RCM/OCT imaging and radiation therapy by the investigator.

Inclusion Criteria

I can complete health surveys in English or Spanish.

My skin cancer has not grown deep into my skin.

I have been diagnosed with basal cell carcinoma through a biopsy.

See 10 more

Exclusion Criteria

I am willing to follow all treatment and follow-up procedures.

I've had radiotherapy that now makes further radiation unsafe, according to my doctor.

Medical contraindication to radiation therapy in the opinion of the investigator

See 1 more

Treatment Details

Interventions

Radiation Therapy (Other)
Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided (Other)

Trial OverviewThe study tests if guiding radiation therapy with a new device combining reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) is effective in treating BCC. It also examines side effects of this guided RT and assesses patients' quality of life before and after treatment through questionnaires.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation TherapyExperimental Treatment2 Interventions

If eligible, patients will undergo pretreatment RCM/OCT imaging, followed by RT. Six weeks after the completion of RT, patients will undergo post-treatment assessment with RCM/OCT and biopsy. If residual carcinoma is detected on the biopsy, surgical excision of the BCC will be performed. If no residual carcinoma is detected on the biopsy, the patient will be monitored for clinical evidence of recurrence for up to 3 years.

Radiation Therapy is already approved in Canada, Japan, China, Switzerland for the following indications: