Using confocal microscopy to assess surgical margins during cancer surgery
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)
This study tests if using a special imaging technique during cancer surgery can help doctors see if they've removed all of the tumor in patients with certain types of skin cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut de Cancérologie de Lorraine Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT05935995 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of confocal microscopy in detecting surgical margins in patients undergoing surgery for squamous cell carcinoma of the head and neck and basal cell carcinoma of the skin. The approach involves comparing confocal microscopy results with traditional histopathological examination to determine its accuracy and reliability. Adult patients with tumors of specific sizes and types will be included, and the study aims to improve surgical outcomes by ensuring complete tumor removal.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with squamous or basal cell tumors measuring 1 to 4 cm.
Not a fit: Patients with a history of irradiation in the surgical area or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could lead to more accurate surgical margins, reducing the likelihood of cancer recurrence.
How similar studies have performed: Other studies have shown promising results using confocal microscopy for similar applications, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patient ≥18 years old * Squamous cell or basal cell tumor (1 to 4 cm) of mucous or cutaneous origin. * Patient whose surgical indication has been validated in a consultation meeting * Patients with scheduled surgery * WHO\< or =2 * ASA \< 3 * Patient affiliated to the social security system * Patient has understood, signed and dated the consent form. Exclusion Criteria: * History of irradiation in the surgical area * Women who are pregnant or who are breast-feeding. * Persons deprived of their liberty or under guardianship (including curators)
Where this trial is running
Vandœuvre-lès-Nancy
- Gilles Dolivet — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Gilles Dolivet, Md — Institut de Cancérologie de Lorraine
- Study coordinator: JEAN LOUIS MERLIN, PharmD, PhD
- Email: jl.merlin@nancy.unicancer.fr
- Phone: +33383656062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.