5-AminoLevulinic Acid for Cancer

(5-ALARMS Trial)

Overseen By Gregory Ottenberg

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Colorado, Denver

Must not be taking: Phototoxic substances

Disqualifiers: Porphyria, Uncontrolled illness, Recent chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Steven Thorpe, MD, FACS

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals with soft tissue sarcoma, a type of cancer. Participants will take an oral agent before surgery to help the surgeon see the tumor better during removal.

Inclusion Criteria

I can swallow pills.

I can understand and am willing to sign a consent form.

I am 18 years old or older.

Exclusion Criteria

I do not have any form of porphyria.

I had cancer treatment or surgery less than 3 weeks ago.

I plan to use medications that may make my skin more sensitive to light.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants are administered 5-ALA orally 3-4 hours prior to surgery

1 day

1 visit (in-person)

Surgery

5-ALA fluorescence-guided surgery is performed to resect the soft-tissue sarcoma

Day of surgery

1 visit (in-person)

Follow-up

Participants are monitored for oncologic outcomes and local recurrence free survival

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 5-Aminolevulinic Acid (5-ALA)

Trial Overview The study tests if using 5-Aminolevulinic acid (5-ALA) helps surgeons see and remove tumors more effectively by making them glow under special light during surgery.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

NX Development Corp

Industry Sponsor

Trials

4

Recruited

330+