Fluorescence-guided Surgery in Patients with Soft Tissue Sarcoma, FLARES Trial

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
• Eastern Cooperative Oncology Group (ECOG) performance status 0 – 1
• Leukocytes ≥ 3 × 10^9/L
• Absolute neutrophil count ≥ 1.5 x 10^9/L
• Platelets ≥ 100 x 10^9/L, transfusions may be used to raise platelets to ≥ 100 x 10^9/L (no washout required)
• Hemoglobin ≥ 9 g/dL, transfusions may be used to raise hemoglobin (Hgb) to ≥ 9 g/dL (no washout required)
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
• Aspartate transaminase (AST)/alanine transaminase (ALT) =< 2.5 x institutional ULN
• Creatinine within normal institutional limits OR creatinine clearance >= 30 mL/min/1.73 m^2 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