Brain and Central Nervous System Tumors Clinical Trial
Official title:
Fluorescence-Guided Detection of Malignant Gliomas: A Dose Ranging Study Using 5-Aminolevulinic Acid (ALA) Induced Protoporphyrin (PpIX) in a Multicenter Phase II Clinical Trial
Verified date | September 2021 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Imaging procedures that use aminolevulinic acid (ALA) may help find and diagnose residual tumor in participants with grade IV malignant astrocytoma who are undergoing surgery to remove the tumor. PURPOSE: Our primary long-term goal is to improve the completeness of surgical resection of malignant brain tumor through image- guided fluorescence localization. We hypothesize that the use of qualitative fluorescence imaging and point PpIX concentration quantification will enable more complete tumor resection than normal direct (i.e., white light) visualization, and thereby improve participant survival.
Status | Completed |
Enrollment | 73 |
Est. completion date | October 14, 2018 |
Est. primary completion date | September 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Tumor Pathology: Newly diagnosed or recurrent malignant gliomas WHO grade IV - Location: Supratentorial - Resection: Tumor must be judged suitable for resection on the basis of imaging studies. - Consent: Participants must be able to give written, informed consent as approved by the local IRB - Newly Diagnosed Tumors: Participants with newly diagnosed Grade IV glioma who have had not been previously treated with cranial radiation therapy - Recurrent Tumors: Participants with recurrent Grade IV gliomas who have failed cranial radiation therapy Exclusion Criteria: - Pregnant women or those who are breast feeding - Individuals with history of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis - Individuals with history of liver disease in last 12 months - Individuals with AST, ALT, ALP, or bilirubin >2.5x normal upper limit any time during the previous 2 months - Individuals with plasma creatinine>180 µmol/L - Individuals who are unable to comply with photosensitivity precautions - Individuals without a grade IV glioma |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Andrew Sloan, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess 2 doses of 5-ALA | This clinical trial has ALA dose at 2 levels (10 and 20 mg/kg) and ALA administration time at 1 time point (6h). During surgery, the intraoperative fluorescence observations and PpIX concentration measurements will be taken by the surgeon. The second part of each biopsy will have the PpIX concentration determined. | 6 hours before midpoint of surgery | |
Secondary | Correlation between intensity of in vivo fluorescence and the pathologist's quantification of tumor in biopsy specimens (e.g., percentage of tumor present) as measured by PpIX concentration and intra-operative fluorescence intensity | readings will be taken at the biopsied location with the PpIX point probe by the surgeon. | Quantitative fluorescence imaging of tumor tissue and normal tissue at approximately the midpoint of surgery and then after maximal resection of the tumor. | |
Secondary | Correlation between the amount and location of residual tumor detected intraoperatively by fluorescence imaging and frameless stereotaxy after maximal resection and the post-operative image enhancement on CT scan and/or MRI | Tumor tissue samples are obtained at the same two timepoints (the midpoint of surgery and then after maximal resection of the tumor) |
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