5-AminoLevulinic Acid Aided Resection Margins in Sarcoma (5-ALARMS)
University of Colorado, Denver
Summary
The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histological confirmation of any subtype of primary Grades 2 or 3 soft tissue sarcomas (STS), per biopsy evaluation by a pathologist, according to Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC). 2. Treatment decision includes planned surgical resection of STS. 3. Age ≥18 years at time of consent. 4. ECOG Performance Status 0 - 1. 5. Hematology and blood chemistry parameters defined by: 1. Leukocytes ≥ 3 × 10(9)/L 2. Absolute neutrophil count ≥ 1.5 × 10(9)/L 3. Platelets ≥ 100 × 109/L, transfusions may be used to raise platelets to ≥ 100 ×…
Interventions
- Drug5-ALA
5-ALA), also known by its brand name Gleolan, is an intermediate in the heme synthesis pathway that has been studied in tumor resections, especially in intracranial tumor resections. One advantage of intraoperative visualization with 5-ALA is the ability to directly visualize fluorescent tumor in the surgical field using a headset-mounted devices with fluorescence in the visual wavelength in real-time.
Location
- University of Colorado HospitalAurora, Colorado