Basal Cell CarcinomaNCT00449358
Checking Wether the m-ALA Cream Could Mark Correctly the Borders of BCC's Tumors
A study testing apply methyl-ALA cream in people with Basal Cell Carcinoma, run by Assuta Hospital Systems at 1 site in Israel.
Trial summary
Correlation between Mohs surgery and microscopic fluorescence photometry in determination of histological borders in Basal Cell Carcinoma . 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?
- apply methyl-ALA cream
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2006to Apr 2013
- 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
- A- bove 18 years
Who cannot join
- Childern
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .
Correlation between Mohs surgery and microscopic fluorescence photometry in determination of histological borders in Basal Cell Carcinoma .
Read the detailed description
Background: Basal Cell Carcinoma (BCC) is the most common form of nonmelanoma skin cancer worldwide. BCCs are slow-growing, locally invasive tumors that rarely metastasize but can cause extensive morbidity through local tissue destruction. Recurrence is often the consequence of incomplete removal of the cancer tissue. Mohs' micrographic surgery is considered the most effective treatment modality for BCC with a recurrence rate of less than 5 %, however, the technique requires specialized training and is labor-intensive and costly. Fluorescence imaging by topical application of a tumor-localizing agent such as methyl 5-aminolevulinic acid (MAL), resulting in buildup of photosensitizing porphyrin IX (PpIX) that can be visualized by Woods' light fluorescence, might serve as a quick and simple "bed-side" technique for demarcation of BCC tumor borders prior to surgical excision Objective: To test the reliability of MAL-induced porphyrin fluorescence tumor demarcation by comparison with the tumor borders determined by Mohs' surgery Methods: Twenty eight patients with facial BCCs (17 nodular, 3 superficial, 1 morphea type, 3 ulcerated and 4 recurrent tumors) scheduled for Mohs' surgery were recruited for the study. The night before the surgical procedure, crusts were gently removed and an approximately 1 mm thick layer of a cream containing 16 % MAL (MetvixR) was applied to the tumor area as well as to the surrounding skin and covered by a transparent occlusive dressing. The following morning (10-17 hours after MetvixR application), the dressing was removed, and the lesion size was determined with a caliber by measuring the largest perpendicular diameters under natural (clinical size) and Woods' (fluorescence size) illumination. The patients then underwent the scheduled Mohs' surgical procedure, and the tumor size (Mohs' size) was determined when reaching the tumor free margins.
- Conditions
- Basal Cell Carcinoma
- Being tested
- apply methyl-ALA cream
- Keywords
- bcc
- 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.
apply methyl-ALA creamProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the tumor area measured with the PDD thechnique and the actual tumor size found at the end of the Mohs surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startFeb 2006
- Study completionApr 2013 (estimated)
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants
Sponsor and investigators
- Lead sponsor
- Assuta Hospital Systems
- Sponsor type
- University, hospital or other
- Investigators
- Enk David, m.d, phd, Principal investigator, Hadassah ein-karem university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449358
- Sponsor's protocol ID
- 1
- Status last verified
- Jan 2006
- First submitted
- 19 Mar 2007
- Last updated
- 16 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Mohs Surgery and Microscopic Fluorescence Photometry in Determination of Histological Borders in Basal Cell Carcinoma .
- ClinicalTrials.gov ID
- NCT00449358
- Acronym / sponsor ID
- 1
- Conditions
- Basal Cell Carcinoma
- Keywords
- bcc
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants
- Lead sponsor
- Assuta Hospital SystemsUniversity, hospital or other
- Study start
- Feb 2006
- Study completion
- Apr 2013 (estimated)
- First posted
- 20 Mar 2007 (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.
Correlation between Mohs surgery and microscopic fluorescence photometry in determination of histological borders in Basal Cell Carcinoma .
Detailed description
Background: Basal Cell Carcinoma (BCC) is the most common form of nonmelanoma skin cancer worldwide. BCCs are slow-growing, locally invasive tumors that rarely metastasize but can cause extensive morbidity through local tissue destruction. Recurrence is often the consequence of incomplete removal of the cancer tissue. Mohs' micrographic surgery is considered the most effective treatment modality for BCC with a recurrence rate of less than 5 %, however, the technique requires specialized training and is labor-intensive and costly. Fluorescence imaging by topical application of a tumor-localizing agent such as methyl 5-aminolevulinic acid (MAL), resulting in buildup of photosensitizing porphyrin IX (PpIX) that can be visualized by Woods' light fluorescence, might serve as a quick and simple "bed-side" technique for demarcation of BCC tumor borders prior to surgical excision Objective: To test the reliability of MAL-induced porphyrin fluorescence tumor demarcation by comparison with the tumor borders determined by Mohs' surgery Methods: Twenty eight patients with facial BCCs (17 nodular, 3 superficial, 1 morphea type, 3 ulcerated and 4 recurrent tumors) scheduled for Mohs' surgery were recruited for the study. The night before the surgical procedure, crusts were gently removed and an approximately 1 mm thick layer of a cream containing 16 % MAL (MetvixR) was applied to the tumor area as well as to the surrounding skin and covered by a transparent occlusive dressing. The following morning (10-17 hours after MetvixR application), the dressing was removed, and the lesion size was determined with a caliber by measuring the largest perpendicular diameters under natural (clinical size) and Woods' (fluorescence size) illumination. The patients then underwent the scheduled Mohs' surgical procedure, and the tumor size (Mohs' size) was determined when reaching the tumor free margins.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A- bove 18 years
Key exclusion criteria (2 listed)
- Childern
- Pregnant women
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 |
|---|---|---|
| apply methyl-ALA cream | Procedure or surgery | – |
Primary outcome
comparing the tumor area measured with the PDD thechnique and the actual tumor size found at the end of the Mohs surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2013.
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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.
Enk David, m.d, phd principal investigator
Hadassah ein-karem university hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apply methyl-ALA cream in people with Basal Cell Carcinoma, run by Assuta Hospital Systems at 1 site in Israel.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Apr 2013. 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 Israel. 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?
Results are not available in the source record.
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?
comparing the tumor area measured with the PDD thechnique and the actual tumor size found at the end of the Mohs surgery. 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 16 Apr 2013.