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5-AminoLevulinic Acid Aided Resection Margins in Sarcoma

ConditionSoft Tissue Sarcoma (STS)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 5-ALA

    Drug

    5-ALA), also known by its brand name Gleolan, is an intermediate in the heme synthesis pathway that has been studied in tumor resections, especially in intracranial tumor resections. One advantage of intraoperative visualization with 5-ALA is the ability to directly visualize fluorescent tumor in the surgical field using a headset-mounted devices with fluorescence in the visual wavelength in real-time.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues

Patients will receive 5-ALA administered in the preoperative area. Surgical resection of the soft tissue sarcoma will be done as per standard of care. A fluorescent headset will be turned on at defined time points below and tumor fluorescence will be noted (yes or no): 1. prior to skin incision 2. once dissection has reached fascial layer 3. when 50% of the tumor superficial-to-deep has been dissected 4. following complete resection of the tumor.

Time frame
From enrollment to 2 weeks
2

Surgeon survey results of intraoperative tumor fluorescence

Surgeons will fill out survey (yes or no) to answer following intraoperative assessment questions: 1. if the tumor demonstrated fluorescence from 5-ALA 2. Was the tumor fluorescence discernable from normal tissue. 3. Did the 5-ALA use increase or decrease the resection amount 4. Was the equipment was easy to use

Time frame
perioperative/periprocedural

Secondary outcomes

1

Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of non-fluorescing samples after tumor removal

The sarcoma tumor will then be hemisected immediately after resection in pathology lab. The fluorescent headset will be used to identify areas of fluorescence in the tumor. Multiple samples (3mm punch) will be taken from nonfluorescent areas and placed on slides: Histologic analysis will evaluate for viable tumor cells (%). For this, Sensitivity will be considered as the proportion of cells who had viable tumor that fluoresced, with specificity as the proportion of cells that had non-viable tumor without fluorescence.

Time frame
Day of Surgery
2

Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal

Description: The sarcoma tumor will then be hemisected immediately after resection in pathology lab. The fluorescent headset will be used to identify areas of fluorescence in the tumor. Multiple samples (3mm punch) will be taken from these fluorescent areas in the tumor and placed on slides: Specific to the margins and include the relevant presence of fluorescence (yes/no), cancer cells(%). For this, Sensitivity will be considered as the proportion of cancerous cells that fluoresced, with specificity as the proportion of non-cancerous cells that did not.

Time frame
Day of surgery
3

Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal

The sarcoma tumor will then be hemisected immediately after resection in pathology lab. The fluorescent headset will be used to identify areas of fluorescence in the tumor. Multiple samples (3mm punch) will be taken from these fluorescent areas in the tumor and placed on slides: These will be specific to the tumor and include the relevant presence of fluorescence (yes/no), viable tumor cells (%). For this, Sensitivity will be considered as the proportion of cells who had viable tumor that fluoresced, with specificity as the proportion of cells that had non-viable tumor without fluorescence.

Time frame
Day of surgery
4

Determine oncologic outcomes for patients enrolled

Local recurrence free survival will be determined from time of surgery and with use of MRI with contrast

Time frame
From enrollment to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: