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New treatment option for Brain Cancer
Official title Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker
ClinicalTrials.gov ID: NCT02691923
What this study is testing
What is Fluorescein?
Fluorescein is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for brain cancer.
Also referred to as Fluorescite.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical research will evaluate the diagnostic potential of fluorescein as visualized through an operating microscope relative to 1) contrast enhancement on co-registered preoperative MR scans, 2) intraoperative ALA-induced PpIX fluorescence and 3) gold-standard histology obtained from biopsy sampling during the procedure. Subjects will include those people with operable brain tumor with first-time presumed pre-surgical diagnosis of high-grade glioma or low-grade glioma.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic...
- Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- Valid informed consent by subject or subject's LAR.
- No serious associated psychiatric illnesses.
- Age ≥ 21 years old.
You likely can't join if
- Pregnant women or women who are breast feeding.
- History of hypersensitivity to fluorescein.
- History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
- History of liver disease within the last 12 months.
- Elevated LFTs (AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to...
- Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery.
See the full eligibility criteria
- Preoperative diagnosis of either presumed first-time low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme).
- Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- Valid informed consent by subject or subject's LAR.
- No serious associated psychiatric illnesses.
- Age ≥ 21 years old.
- Pregnant women or women who are breast feeding.
- History of hypersensitivity to fluorescein.
- History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis.
- History of liver disease within the last 12 months.
- Elevated LFTs (AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery.
- Serum creatinine in excess of 180µmol/L (2.04 md/dL) within 30 days prior to surgery.
- Inability to comply with the photosensitivity precautions associated with the study.
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.