5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

NCT07038278 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 24-2149.cc
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma (STS)

Keywords

soft tissue sarcoma; fluorescence

Outcome Measures

Primary Outcomes (2)

• Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues

  Patients will receive 5-ALA administered in the preoperative area. Surgical resection of the soft tissue sarcoma will be done as per standard of care. A fluorescent headset will be turned on at defined time points below and tumor fluorescence will be noted (yes or no): 1. prior to skin incision 2. once dissection has reached fascial layer 3. when 50% of the tumor superficial-to-deep has been dissected 4. following complete resection of the tumor.

  From enrollment to 2 weeks

• Surgeon survey results of intraoperative tumor fluorescence

  Surgeons will fill out survey (yes or no) to answer following intraoperative assessment questions: 1. if the tumor demonstrated fluorescence from 5-ALA 2. Was the tumor fluorescence discernable from normal tissue. 3. Did the 5-ALA use increase or decrease the resection amount 4. Was the equipment was easy to use

  perioperative/periprocedural

Secondary Outcomes (7)

• Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of non-fluorescing samples after tumor removal

  Day of Surgery

• Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal

  Day of surgery

• Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal

  Day of surgery

• Determine oncologic outcomes for patients enrolled

  From enrollment to 2 years

• Patient Reported Outcomes

  From enrollment to 2 years

Study Arms (1)

Intervention Group

EXPERIMENTAL

Patients diagnosed with Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) Grade 2 or 3 soft tissue sarcomas who undergo surgical resection will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to anesthesia.

Drug: 5-ALA

Interventions

5-ALA DRUG

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.

Also known as: Gleolan

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Treatment decision includes planned surgical resection of STS.
• Age ≥18 years at time of consent.
• ECOG Performance Status 0 - 1.
• Hematology and blood chemistry parameters defined by:
• Leukocytes ≥ 3 × 10(9)/L
• Absolute neutrophil count ≥ 1.5 × 10(9)/L
• Platelets ≥ 100 × 109/L, transfusions may be used to raise platelets to ≥ 100 × 10(9)/L (no washout required)
• Hemoglobin ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required)
• Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
• Aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 2.5 × institutional ULN
• Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine above institutional ULN
• Participants of reproductive potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 42 days after end of study intervention; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy).
• Ability to swallow study agent.
• Ability to understand and willingness to sign an informed consent form.

You may not qualify if:

• Acute/chronic forms of porphyria.
• Uncontrolled, known concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
• Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery.
• Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period.
• Planned use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones and tetracyclines), and topical preparations containing aminolevulinic acid (5-ALA) for 24 hours during the perioperative period (defined as 24 hours prior to surgery to up to 24 hours post-surgery).
• Pregnant or planning to become pregnant during study participation or breastfeeding.
• Any condition that is in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Publications (8)

• 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.

  PMID: 26885645 RESULT

• 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.

  PMID: 36656388 RESULT

• 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.

  PMID: 16648043 RESULT

• 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.

  PMID: 34624862 RESULT

• 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.

  PMID: 30659522 RESULT

• 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.

  PMID: 35033148 RESULT

• 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.

  PMID: 32138774 RESULT

• 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.

  PMID: 30173528 RESULT

MeSH Terms

Conditions

Sarcoma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Steven Thorpe, MD, FACS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory Ottenberg

CONTACT

303-724-0875; gregory.ottenberg@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: June 26, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)