5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

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.

Timeline

Start

2026-04-01

Primary completion

2027-11-01

Completion

2028-11-01

Publications

• Results Teixidor P, Arraez MA, Villalba G, Garcia R, Tardaguila M, Gonzalez JJ, Rimbau J, Vidal X, Montane E. Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study. PLoS One. 2016 Feb 17;11(2):e0149244. doi: 10.1371/journal.pone.0149244. eCollection 2016.
• Results Giantini-Larsen AM, Kharas N, Pisapia D, Schwartz TH. Histology of high-grade glioma samples resected using 5-ALA fluorescent headlight and loupe combination. Acta Neurochir (Wien). 2023 Feb;165(2):567-575. doi: 10.1007/s00701-023-05496-8. Epub 2023 Jan 19.
• Results Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
• Results Schupper AJ, Baron RB, Cheung W, Rodriguez J, Kalkanis SN, Chohan MO, Andersen BJ, Chamoun R, Nahed BV, Zacharia BE, Kennedy J, Moulding HD, Zucker L, Chicoine MR, Olson JJ, Jensen RL, Sherman JH, Zhang X, Price G, Fowkes M, Germano IM, Carter BS, Hadjipanayis CG, Yong RL. 5-Aminolevulinic acid for enhanced surgical visualization of high-grade gliomas: a prospective, multicenter study. J Neurosurg. 2021 Oct 8;136(6):1525-1534. doi: 10.3171/2021.5.JNS21310. Print 2022 Jun 1.
• Results Mahmoudi K, Garvey KL, Bouras A, Cramer G, Stepp H, Jesu Raj JG, Bozec D, Busch TM, Hadjipanayis CG. 5-aminolevulinic acid photodynamic therapy for the treatment of high-grade gliomas. J Neurooncol. 2019 Feb;141(3):595-607. doi: 10.1007/s11060-019-03103-4. Epub 2019 Jan 18.
• Results Guder WK, Hartmann W, Buhles C, Burdack M, Busch M, Dunker N, Hardes J, Dirksen U, Bauer S, Streitburger A. 5-ALA-mediated fluorescence of musculoskeletal tumors in a chick chorio-allantoic membrane model: preclinical in vivo qualification analysis as a fluorescence-guided surgery agent in Orthopedic Oncology. J Orthop Surg Res. 2022 Jan 15;17(1):34. doi: 10.1186/s13018-022-02931-x.
• Results Kenan S, Liang H, Goodman HJ, Jacobs AJ, Chan A, Grande DA, Levin AS. 5-Aminolevulinic acid tumor paint and photodynamic therapy for myxofibrosarcoma: an in vitro study. J Orthop Surg Res. 2020 Mar 5;15(1):94. doi: 10.1186/s13018-020-01606-9.
• Results Endo M, Lin PP. Surgical margins in the management of extremity soft tissue sarcoma. Chin Clin Oncol. 2018 Aug;7(4):37. doi: 10.21037/cco.2018.08.10.

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