Basal Cell CarcinomaNCT04510727
Optical Coherence Tomography Guided C&D
A study testing Optical Coherence Tomography (OCT) and Curettage & Desiccation (C&D) Procedure in people with Basal Cell Carcinoma, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (BCC) status-post curettage and desiccation (C\&D) by using optical coherence tomography (OCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- Optical Coherence Tomography (OCT) and Curettage & Desiccation (C&D) Procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of any: age, gender, Fitzpatrick skin type and ethnicity.
- Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery
- No prior treatment on the lesion within the last 3 months.
- Lesions anywhere except the head, neck and distal extremities.
- Willing and able to sign informed consent
Who cannot join
- Aggressive BCC types.
- Recurrent tumors.
- Lesion treated within last 3 months.
- Lesions on head and neck (high risk areas)
- Lesions on distal extremities (thin epidermis not preferred for OCT).
- Pregnant women.
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- Patients less than 18 years old.
- Prisoners.
- Any other condition or circumstance that, in the opinion of the Investigator, may compromise the subject's ability to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using OCT Imaging to Determine the Presence of Residual Tumor Cells After C&D for Superficial and Nodular BCC: A Prospective Study.
The purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (BCC) status-post curettage and desiccation (C\&D) by using optical coherence tomography (OCT).
- Conditions
- Basal Cell Carcinoma
- Being tested
- Optical Coherence Tomography (OCT), Curettage & Desiccation (C&D) Procedure
- Keywords
- Superficial basal cell carcinoma, Nodular basal cell carcinoma
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT)Device
VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.
Curettage & Desiccation (C&D) ProcedureProcedure or surgery
Standard of care C\&D where the basal cell carcinoma lesion will be scraped to its base using a Fox dermal curette and an electrodesiccation machine.
| Study group | Role | What they receive |
|---|---|---|
| OCT Guided C&D Group | Experimental | Participants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C\&D. Receives: Device: Optical Coherence Tomography (OCT); Procedure: Curettage & Desiccation (C&D) Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of residual basal cell carcinoma tumor cells
The incidence of residual superficial and nodular basal cell carcinoma tumor cells after standard of care C\&D as assessed using the OCT.
Measured: 2 months (post C&D procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Apr 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Why it stopped: device not available to initiate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keyvan Nouri, University of Miami
- Investigators
- Keyvan Nouri, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04510727
- Sponsor's protocol ID
- 20200212
- Status last verified
- Feb 2024
- First submitted
- 9 Aug 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using OCT Imaging to Determine the Presence of Residual Tumor Cells After C&D for Superficial and Nodular BCC: A Prospective Study.
- ClinicalTrials.gov ID
- NCT04510727
- Acronym / sponsor ID
- 20200212
- Conditions
- Basal Cell Carcinoma
- Keywords
- Superficial basal cell carcinoma, Nodular basal cell carcinoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: device not available to initiate study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to identify the presence of residual superficial and nodular basal cell carcinoma (BCC) status-post curettage and desiccation (C\&D) by using optical coherence tomography (OCT).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT Guided C&D Group | Experimental | Device: Optical Coherence Tomography (OCT), Procedure: Curettage & Desiccation (C&D) ProcedureParticipants in this group will receive OCT imaging immediately prior, immediately after and 2 months after post standard of care C\&D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of any: age, gender, Fitzpatrick skin type and ethnicity.
- Primary BCC of any type, except aggressive types that fit the criteria for Mohs surgery
- No prior treatment on the lesion within the last 3 months.
- Lesions anywhere except the head, neck and distal extremities.
- Willing and able to sign informed consent
Key exclusion criteria (9 listed)
- Aggressive BCC types.
- Recurrent tumors.
- Lesion treated within last 3 months.
- Lesions on head and neck (high risk areas)
- Lesions on distal extremities (thin epidermis not preferred for OCT).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography (OCT)VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin. | Device | OCT Guided C&D Group |
| Curettage & Desiccation (C&D) ProcedureStandard of care C\&D where the basal cell carcinoma lesion will be scraped to its base using a Fox dermal curette and an electrodesiccation machine. | Procedure or surgery | OCT Guided C&D Group |
Primary outcome
The incidence of residual basal cell carcinoma tumor cells
Time frame: 2 months (post C&D procedure)
The incidence of residual superficial and nodular basal cell carcinoma tumor cells after standard of care C\&D as assessed using the OCT.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keyvan Nouri, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography (OCT) and Curettage & Desiccation (C&D) Procedure in people with Basal Cell Carcinoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of residual basal cell carcinoma tumor cells (time frame: 2 months (post C&D procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.