5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

Phase 1

Not yet recruiting

• Conditions: Soft Tissue Sarcoma (STS)
• Interventions: Drug: 5-ALA

• Registration Number: NCT07038278
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-09
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2027-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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 × 10(9)/L (no washout required)
   4. Hemoglobin ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required)
   5. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
   6. Aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 2.5 × institutional ULN
   7. Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine above institutional ULN

6. 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).

7. Ability to swallow study agent.

8. Ability to understand and willingness to sign an informed consent form.

9. Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study.

Inclusion of Minorities and Other Underrepresented Populations Recruitment is open and encouraged to all genders, all minorities, and underrepresented populations. Although distributions may vary by disease type, our recruitment procedures have been developed to enroll participants who are representative of the respective target population.

Exclusion Criteria

1. Acute/chronic forms of porphyria.
2. 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.
3. Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery.
4. Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period.
5. 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).
6. Pregnant or planning to become pregnant during study participation or breastfeeding.
7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	5-ALA	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.

Primary Outcome Measures

Name	Time	Method
Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues	From enrollment to 2 weeks	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.
Surgeon survey results of intraoperative tumor fluorescence	perioperative/periprocedural	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

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes	From enrollment to 2 years.	Visual Analog Scales (VAS) patient reported outcome measure.
Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of non-fluorescing samples after tumor removal	Day of Surgery	The sarcoma tumor will then be hemisected immediately after resection in pathology lab.; The fluorescent headset will be used to identify areas of fluorescence in the tumor.; Multiple samples (3mm punch) will be taken from nonfluorescent areas and placed on slides: Histologic analysis will evaluate for viable tumor cells (%). For this, Sensitivity will be considered as the proportion of cells who had viable tumor that fluoresced, with specificity as the proportion of cells that had non-viable tumor without fluorescence.
Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal	Day of surgery	The sarcoma tumor will then be hemisected immediately after resection in pathology lab.; The fluorescent headset will be used to identify areas of fluorescence in the tumor.; Multiple samples (3mm punch) will be taken from these fluorescent areas in the tumor and placed on slides: These will be specific to the tumor and include the relevant presence of fluorescence (yes/no), viable tumor cells (%). For this, Sensitivity will be considered as the proportion of cells who had viable tumor that fluoresced, with specificity as the proportion of cells that had non-viable tumor without fluorescence.
Determine oncologic outcomes for patients enrolled	From enrollment to 2 years	Local recurrence free survival will be determined from time of surgery and with use of MRI with contrast

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States