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RCM/OCT-Guided Radiation Therapy for Basal Cell Carcinoma
Phase 2
Recruiting
Led By Christopher Barker, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No deep invasion (beyond subcutaneous fat or >6 mm from granular layer of dermis to deepest point of carcinoma)
Biopsy proven basal cell carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Study Summary
This trial will test a new cancer treatment device to see if it is effective against basal cell carcinoma, as well as look at any potential side effects. The device uses radiation therapy, and researchers will also study quality of life before and after treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects are not listed, typical ones from radiation therapy may include skin irritation, redness, peeling at the treatment site, fatigue, mild swelling, or changes in skin coloration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin cancer has not grown deep into my skin.
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I have been diagnosed with basal cell carcinoma through a biopsy.
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My cancer has not spread to my nerves.
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My cancer is in an early stage (T1 or T2).
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My cancer lesion is 40 mm or smaller.
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My cancer has not damaged my bones.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
histologic tumor response rate
Secondary outcome measures
frequency and severity of adverse events
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Physical Sciences Inc.UNKNOWN
1 Previous Clinical Trials
15 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,860 Total Patients Enrolled
Christopher Barker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
314 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.I can have up to 3 tumors treated at the same time or at different times.Some parts of your body may not be suitable for certain imaging tests called RCM or OCT.My doctor agrees I can undergo specific imaging and radiation therapy.My cancer has not spread to my nerves.My cancer is in an early stage (T1 or T2).My cancer lesion is 40 mm or smaller.My cancer has not damaged my bones.I am 18 years old or older.I do not have conditions that make me overly sensitive to radiation or prevent treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Reflectance ConfocaL Microscopy And Optical Coherence Tomography Guided RadIation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being accepted to partake in this trial?
"Affirmative. Per information on clinicaltrials.gov, this trial has been open since March 3rd 2022 and was last modified on August 25th 2022. The research is looking to enlist 32 participants from 7 different sites around the country."
Answered by AI
Are there any US-based medical facilities conducting research on this topic?
"As of now, seven sites are open for patient enrollment into this medical trial. These include the Memorial Sloan Kettering Nassau (Limited Protocol Activities) in Uniondale, MSK Basking Ridge (Limited Protocol Activities) in Basking Ridge and the MSK Monmouth (Limited Protocol Activities) in Middletown alongside four other locations."
Answered by AI
Is enrollment still open for participants in the trial?
"Indeed, the information accessible on clinicaltrials.gov confirms that recruitment for this medical trial is ongoing. This study was first shared in March of 2022 and has been updated most recently on August 25th of the same year. The investigators are searching to enlist 32 patients over 7 sites."
Answered by AI
What risks does Radiation Therapy pose to patients?
"Our analysts at Power rate the safety of Radiation Therapy as a 2 due to evidence collected from Phase 2 trials, suggesting some security but no proof of efficacy."
Answered by AI
Who else is applying?
What site did they apply to?
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
What portion of applicants met pre-screening criteria?
Met criteria
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