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Procedure

Aminolevulinic acid (5-ALA) for Soft Tissue Sarcoma

Phase 1

Waitlist Available

Led By Steven W Thorpe, MD

Research Sponsored by Steven W Thorpe

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment decision includes planned surgical resection of STS

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

"This trial will study 20 patients with soft tissue sarcomas undergoing surgery. Patients will take 5-ALA before surgery to help identify tumor margins using fluorescence."

Who is the study for?

This trial is for patients with Grade 2 or 3 soft tissue sarcomas, who are scheduled for surgical removal of their tumor. Participants must be able to take the study drug orally before surgery.Check my eligibility

What is being tested?

The trial tests if a drug called Aminolevulinic Acid (5-ALA), taken orally, helps surgeons see cancerous tissues better during surgery. The goal is to improve the precision of tumor removal in soft tissue sarcoma patients.See study design

What are the potential side effects?

Potential side effects from Aminolevulinic Acid may include sensitivity to light, nausea, vomiting, liver enzyme changes, and skin reactions. These are based on known responses to similar procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to remove my soft tissue sarcoma.

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My biopsy shows I have Grade 2 or 3 soft tissue sarcoma.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My blood tests meet the required levels for white cells, platelets, hemoglobin, liver and kidney function.

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I can swallow pills.

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I can and will follow the study's schedule and rules.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of 5-ALA-aided fluorescent visualization of STS versus surrounding tissues

Secondary outcome measures

Disease free survival.

Efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal.

Incidence of treatment related adverse events.

Side effects data

From 2016 Phase 2 trial • 166 Patients • NCT02239679

17%

basal cell carcinoma

11%

squamous cell carcinoma of skin

squamous cell carcinoma

100%

80%

60%

40%

20%

Study treatment Arm

ALA X2

ALA X3

VEH-PDT

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aminolevulinic acid (5-ALA)Experimental Treatment1 Intervention

20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to surgical resection. 5-ALA fluorescence will be used to evaluate the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aminolevulinic Acid

2015

Completed Phase 4

~430

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Steven W ThorpeLead Sponsor

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,252 Total Patients Enrolled

Steven W Thorpe, MDPrincipal InvestigatorUniversity of California, Davis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"As per the details provided on clinicaltrials.gov, recruitment for this specific clinical trial is currently closed. The trial's initial posting was on March 1st, 2024, with the latest update made on February 2nd, 2024. Although this particular study is not actively seeking participants, there are numerous other trials - a total of 439 - that are open for enrollment at present."

Answered by AI

Has the Food and Drug Administration endorsed Aminolevulinic acid (5-ALA) for medical use?

"Given that this is a Phase 1 trial with minimal safety and efficacy data, our team at Power rates the safety of Aminolevulinic acid (5-ALA) as 1 on a scale of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)

Steven W Thorpe 2024. "Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06252727.

All > Soft Tissue Sarcoma