NCT01898416View on ClinicalTrials.gov

Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors

PHASE2RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2026

Conditions
The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as anAdjuvant Therapy on the Clinical Outcome of Patients With Desmoid Tumors AfterSurgical Resection
Interventions
DRUG

5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.

"60 mg/kg 5-ALA prepared solution given orally, 3-5 hours before induction of anesthesia.~Red light laser given by a Dye laser system, wave length of 635nm, in s dose of 150J/cm for 2000 seconds (33 minutes) will be given to tumor bed. In case of positive margins a second operation and 5-ALA administration or irradiation will be given."

Trial Locations (2)

64239

RECRUITING

Tel Aviv sourasky medical center, Tel Aviv

RECRUITING

The Aviv Sourasky Medical Center, Tel Aviv

All Listed Sponsors
lead

michal roll

OTHER_GOV