Eyelid Sebaceous Gland Carcinoma
Conditions
Brief summary
This phase II trial studies how well lymph node mapping works in finding disease that has spread from the place where it started to other places in the body in patients with sebaceous gland cancer of the eyelid. Lymph node mapping may help in planning surgery to remove cancer and affected lymph nodes.
Detailed description
PRIMARY OBJECTIVES: I. Identify the rate of SLN (sentinel lymph node) positivity for eyelid sebaceous gland carcinomas. II. Identify the false negative events associated with SLN biopsy for sebaceous gland carcinomas. SECONDARY OBJECTIVE: I. Record any side effects associated with SLN biopsy for sebaceous gland carcinoma of the eyelid. OUTLINE: Patients receive technetium Tc 99m sulfur colloid intradermally (ID) and then undergo lymph node mapping and SLN biopsy. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
Interventions
PROCEDURELymph Node Mapping
Undergo lymph node mapping
PROCEDURESentinel Lymph Node Biopsy
Undergo SLN biopsy
Given ID
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Possible or suspicious sebaceous gland carcinoma of the eyelid * A CXR (chest x-ray), liver enzymes, and a head and neck computed tomography (CT), a single photon emission computed tomography (SPECT/CT) or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis * Patient provided written informed consent; in the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an informed consent document (ICD) in their language, will be utilized and completed in accordance with the M.D. Anderson Cancer Center (MDACC) Policy for Consenting Non-English Speaking Participants
Exclusion criteria
* Pregnant or nursing females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel Lymph Node Positivity | One year after the surgical procedure under study. | Number of patients who had a positive sentinel lymph node |
Countries
United States
Participant flow
Recruitment details
Patients with sebaceous carcinoma of the eyelid treated at MDA from 2009-2021
Participants by arm
| Arm | Count |
|---|---|
| Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid Patients with sebaceous carcinoma who opted to receive SLN biopsy | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Sentinel Lymph Node Positivity
Number of patients who had a positive sentinel lymph node
Time frame: One year after the surgical procedure under study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sentinel Lymph Node Localization and Biopsy for Sebaceous Gland Carcinoma of the Eyelid | Sentinel Lymph Node Positivity | 2 Participants |