Squamous Cell Carcinoma (SCC)NCT02750033
Intraoperative Margin Assessment During Mohs Surgery
An observational study of Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC), run by Seton Healthcare Family.
Trial summary
The research team will develop an intraoperative handheld device for assessing surgical margins during Mohs surgery. The device technology is based on multimodal optical spectroscopy (MMS), combining three optical spectroscopy techniques into one device. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Squamous Cell Carcinoma (SCC), Basal Cell Carcinoma (BCC)
- What is being tested?
- Multimodal Spectroscopy (MMS)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 2017
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing Mohs surgery to remove basal or squamous cell carcinoma.
Who may be able to join
- Male or Female and over 18 years of age.
- Patients undergoing Mohs surgery for SCC or BCC
Who cannot join
- Male or Female and under 18 years of age.
- Patients with diagnosis other than SCC or BCC
About this study
The research team will develop an intraoperative handheld device for assessing surgical margins during Mohs surgery. The device technology is based on multimodal optical spectroscopy (MMS), combining three optical spectroscopy techniques into one device. The researchers will first acquire proof of concept MMS measurements within the Mohs surgery suite immediately after surgical excision and prior to histological processing. MMS measurements will be acquired directly on the patient from the NMSC excision site. The final outcome of this study will result in the sensitivity and specificity of MMS compared to histopathology during Mohs surgery. These results will allow for the estimation of the potential benefit of an intraoperative margin assessment technique.
Read the detailed description
Acquire intraoperative MMS measurements in vivo. After assessing this approach on excised tissues, MMS measurements will be aquired directly on the patient from the NMSC excision site. MMS data will be acquired on patients being treated for NMSC at the Austin Dermatologic Surgery Center, the surgical site for the dermatology practice of Seton/University of Texas Physicians group. Similar to the measurements on freshly excised tissues, MMS data will be acquired in a grid pattern on the excision site. The site will be blotted with gauze to remove residual blood prior to the measurement, and continuously blotted as needed until all measurements have been taken. The handheld probe of the MMS enables assessment of both the wound periphery and deeper layers of tissue to determine if any tumor is remaining. For this initial pilot study, we plan to take measurements on 10 patients (5 BCC, 5 SCC), along with corresponding normal tissue measurements.
Retrospective analysis of MMS sensitivity and specificity. The MMS technique is an information rich modality providing both morphological and functional parameters of the interrogated tissue that could be correlated to known tumor pathology. However, this extracted information will require development of sophisticated spectral analysis models which would be beyond the scope of the current study. Therefore, for the purpose of this study, standard statistical techniques will be used to determine the classification power of MMS for tumor margin detection. While this approach does not fully elucidate the underlying pathology responsible for the classification, these types of models have been shown to perform at or better than those based on a morphological approach. This approach has been previously employed to classify skin cancer with high diagnostic accuracy. The final outcome of this study will result in the sensitivity and specificity of MMS compared to histopathology during Mohs surgery. These results will allow for the estimation of the potential benefit of an intraoperative margin assessment technique. This type of retrospective study will provide a proof of concept that would warrant further development and prospective studies of the MMS approach.
- Being tested
- Multimodal Spectroscopy (MMS)
- Medical subject headings
- Carcinoma, Squamous Cell, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Spectroscopy (MMS)Device
surgical margin assessment with multimodal optical spectroscopy (MMS) device
| Study group | Role | What they receive |
|---|---|---|
| Basal Cell Carcinoma (BCC) | Adult patients undergoing Mohs surgery to remove basal cell carcinoma (BCC) will have surgical margins assessed with multimodal optical spectroscopy (MMS) device, as well as standard histopathology evaluation. Receives: Device: Multimodal Spectroscopy (MMS) | |
| Squamous Cell Carcinoma (SCC) | Adult patients undergoing Mohs surgery to remove squamous cell carcinoma (BCC) will have surgical margins assessed with multimodal optical spectroscopy (MMS) device, as well as standard histopathology evaluation. Receives: Device: Multimodal Spectroscopy (MMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of MMS compared to histopathology during Mohs surgery
Measured: May, 2016 to December, 2016 up to 6 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2016
- Study completionMar 2017
Why it stopped: Protocol changed to meet IRB requirements for patient safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma (SCC)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seton Healthcare Family
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas at Austin
- Responsible party
- Principal investigator, Jason Reichenberg, Seton Healthcare Family
- Investigators
- Jason Reichenberg, MD, Principal investigator, Seton Healthcare Family
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750033
- Sponsor's protocol ID
- CR-16-049
- Status last verified
- Aug 2018
- First submitted
- 20 Apr 2016
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Robinson JK. Sun exposure, sun protection, and vitamin D. JAMA. 2005 Sep 28;294(12):1541-3. doi: 10.1001/jama.294.12.1541. No abstract available.
PubMed 16193624Asgari MM, Olson JM, Alam M. Needs assessment for Mohs micrographic surgery. Dermatol Clin. 2012 Jan;30(1):167-75, x. doi: 10.1016/j.det.2011.08.010.
PubMed 22117877Koslosky CL, El Tal AK, Workman B, Tamim H, Durance MC, Mehregan DA. Reliability of skin biopsies in determining accurate tumor margins: a retrospective study after Mohs micrographic surgery. Dermatol Surg. 2014 Sep;40(9):964-70. doi: 10.1097/01.DSS.0000452621.79017.19.
PubMed 25099294Sharma M, Marple E, Reichenberg J, Tunnell JW. Design and characterization of a novel multimodal fiber-optic probe and spectroscopy system for skin cancer applications. Rev Sci Instrum. 2014 Aug;85(8):083101. doi: 10.1063/1.4890199.
PubMed 25173240Lim L, Nichols B, Migden MR, Rajaram N, Reichenberg JS, Markey MK, Ross MI, Tunnell JW. Clinical study of noninvasive in vivo melanoma and nonmelanoma skin cancers using multimodal spectral diagnosis. J Biomed Opt. 2014;19(11):117003. doi: 10.1117/1.JBO.19.11.117003.
PubMed 25375350
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Margin Assessment During Mohs Surgery
- ClinicalTrials.gov ID
- NCT02750033
- Acronym / sponsor ID
- CR-16-049
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Protocol changed to meet IRB requirements for patient safety
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seton Healthcare FamilyUniversity, hospital or other
- Collaborators
- University of Texas at Austin
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Apr 2016 (estimated)
- 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 research team will develop an intraoperative handheld device for assessing surgical margins during Mohs surgery. The device technology is based on multimodal optical spectroscopy (MMS), combining three optical spectroscopy techniques into one device. The researchers will first acquire proof of concept MMS measurements within the Mohs surgery suite immediately after surgical excision and prior to histological processing. MMS measurements will be acquired directly on the patient from the NMSC excision site. The final outcome of this study will result in the sensitivity and specificity of MMS compared to histopathology during Mohs surgery. These results will allow for the estimation of the potential benefit of an intraoperative margin assessment technique.
Detailed description
Acquire intraoperative MMS measurements in vivo. After assessing this approach on excised tissues, MMS measurements will be aquired directly on the patient from the NMSC excision site. MMS data will be acquired on patients being treated for NMSC at the Austin Dermatologic Surgery Center, the surgical site for the dermatology practice of Seton/University of Texas Physicians group. Similar to the measurements on freshly excised tissues, MMS data will be acquired in a grid pattern on the excision site. The site will be blotted with gauze to remove residual blood prior to the measurement, and continuously blotted as needed until all measurements have been taken. The handheld probe of the MMS enables assessment of both the wound periphery and deeper layers of tissue to determine if any tumor is remaining. For this initial pilot study, we plan to take measurements on 10 patients (5 BCC, 5 SCC), along with corresponding normal tissue measurements.
Retrospective analysis of MMS sensitivity and specificity. The MMS technique is an information rich modality providing both morphological and functional parameters of the interrogated tissue that could be correlated to known tumor pathology. However, this extracted information will require development of sophisticated spectral analysis models which would be beyond the scope of the current study. Therefore, for the purpose of this study, standard statistical techniques will be used to determine the classification power of MMS for tumor margin detection. While this approach does not fully elucidate the underlying pathology responsible for the classification, these types of models have been shown to perform at or better than those based on a morphological approach. This approach has been previously employed to classify skin cancer with high diagnostic accuracy. The final outcome of this study will result in the sensitivity and specificity of MMS compared to histopathology during Mohs surgery. These results will allow for the estimation of the potential benefit of an intraoperative margin assessment technique. This type of retrospective study will provide a proof of concept that would warrant further development and prospective studies of the MMS approach.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basal Cell Carcinoma (BCC) | – | Device: Multimodal Spectroscopy (MMS)Adult patients undergoing Mohs surgery to remove basal cell carcinoma (BCC) will have surgical margins assessed with multimodal optical spectroscopy (MMS) device, as well as standard histopathology evaluation. |
| Squamous Cell Carcinoma (SCC) | – | Device: Multimodal Spectroscopy (MMS)Adult patients undergoing Mohs surgery to remove squamous cell carcinoma (BCC) will have surgical margins assessed with multimodal optical spectroscopy (MMS) device, as well as standard histopathology evaluation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing Mohs surgery to remove basal or squamous cell carcinoma.
Key inclusion criteria (2 listed)
- Male or Female and over 18 years of age.
- Patients undergoing Mohs surgery for SCC or BCC
Key exclusion criteria (2 listed)
- Male or Female and under 18 years of age.
- Patients with diagnosis other than SCC or BCC
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 |
|---|---|---|
| Multimodal Spectroscopy (MMS)surgical margin assessment with multimodal optical spectroscopy (MMS) device | Device | Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) |
Primary outcome
Sensitivity and specificity of MMS compared to histopathology during Mohs surgery
Time frame: May, 2016 to December, 2016 up to 6 moths
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 Aug 2018.
- Background: PubMed 16193624Robinson JK. Sun exposure, sun protection, and vitamin D. JAMA. 2005 Sep 28;294(12):1541-3. doi: 10.1001/jama.294.12.1541. No abstract available.
- Background: PubMed 22117877Asgari MM, Olson JM, Alam M. Needs assessment for Mohs micrographic surgery. Dermatol Clin. 2012 Jan;30(1):167-75, x. doi: 10.1016/j.det.2011.08.010.
- Background: PubMed 25099294Koslosky CL, El Tal AK, Workman B, Tamim H, Durance MC, Mehregan DA. Reliability of skin biopsies in determining accurate tumor margins: a retrospective study after Mohs micrographic surgery. Dermatol Surg. 2014 Sep;40(9):964-70. doi: 10.1097/01.DSS.0000452621.79017.19.
- Background: PubMed 25173240Sharma M, Marple E, Reichenberg J, Tunnell JW. Design and characterization of a novel multimodal fiber-optic probe and spectroscopy system for skin cancer applications. Rev Sci Instrum. 2014 Aug;85(8):083101. doi: 10.1063/1.4890199.
- Background: PubMed 25375350Lim L, Nichols B, Migden MR, Rajaram N, Reichenberg JS, Markey MK, Ross MI, Tunnell JW. Clinical study of noninvasive in vivo melanoma and nonmelanoma skin cancers using multimodal spectral diagnosis. J Biomed Opt. 2014;19(11):117003. doi: 10.1117/1.JBO.19.11.117003.
- Individual participant dataSharing planned: Undecided
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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.
Jason Reichenberg, MD principal investigator
Seton Healthcare Family
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC), run by Seton Healthcare Family.
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 2 inclusion and 2 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity and specificity of MMS compared to histopathology during Mohs surgery (time frame: May, 2016 to December, 2016 up to 6 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02750033, which also lists 5 linked publications.
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 Aug 2018; AzTrials last refreshed its copy on 27 Oct 2026.