fluorescent aided resection and evaluation of soft tissue sarcomas (flares)

Conditions: Soft Tissue Sarcoma; Soft Tissue Sarcoma Adult

Summary: this will be a prospective pilot study that will evaluate 20 patients who were diagnosed with fnclcc grade 2 or 3 soft tissue sarcomas and will undergo surgical resection. based upon the fda label, successful protocols used for intraoperative fluorescence-guided visualization for glioma resections, and on drug company current dosing recommendation for this study, patients will be administered 20 mg/kg body weight of 5-ala orally at 3-4 hours prior to surgery. the use of 5-ala fluorescence will be relevant for evaluating the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins.

primary objective: i. demonstrate the feasibility of 5-ala-aided fluorescent visualization of sts versus surrounding tissues. secondary objective: i. demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. ii. assess the safety profile of fluorescence-guided surgery (fgs) for sts utilizing 5-ala. outline: patients will be administered 20 mg/kg body weight of 5-ala orally at 3-4 hours prior to surgical resection. intraoperative fluorescence-guided visualization will be used for evaluating the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins.

Eligibility criteria:
inclusion criteria: * 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 (see appendix) * hematology and blood chemistry parameters defined by: * leukocytes ≥ 3 × 109/l * absolute neutrophil count ≥ 1.5 × 109/l * platelets ≥ 100 × 109/l, transfusions may be used to raise platelets to ≥ 100 × 109/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. * ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study. exclusion criteria: * 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 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.