An interventional study of gallium Ga 68-edotreotide and positron emission tomography in Acoustic Schwannoma, Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, sponsored by Sue O'Dorisio. Withdrawn at 1 site in United States. Open to participants aged 6 Months to 29 Years. Per ClinicalTrials.gov, last updated 2017-04-28.
Sponsored by Sue O'Dorisio · Not applicable, Interventional, and Diagnostic
This pilot clinical trial studies gallium Ga 68-edotreotide (68Ga-DOTATOC) positron emission tomography (PET)/computed tomography (CT) in finding brain tumors in younger patients. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT imaging, may help find and diagnose brain tumors.
PRIMARY OBJECTIVES:
I. To determine if 68Ga-DOTATOC (gallium Ga 68-edotreotide) PET when combined with magnetic resonance imaging (MRI) will differentiate embryonal tumors such as medulloblastoma and supratentorial primitive neuroectodermal tumor (PNET) from the low and high grade gliomas.
II. To determine if 68Ga-DOTATOC PET will aid in the identification of residual tumor post operatively in those patients who were 68Ga-DOTATOC PET positive prior to surgery.
OUTLINE:
Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery.
100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo gallium Ga 68-edotreotide PET/CT at baseline and 1-30 days after surgery. Interventions: gallium Ga 68-edotreotide, positron emission tomography, computed tomography, laboratory biomarker analysis
Radiation: gallium Ga 68-edotreotide · Procedure: positron emission tomography · Procedure: computed tomography · Other: laboratory biomarker analysis
Undergo gallium Ga 68-edotreotide PET/CT
Also known as: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC
Undergo gallium Ga 68-edotreotide PET/CT
Also known as: FDG-PET, PET, PET scan, tomography, emission computed
Undergo gallium Ga 68-edotreotide PET/CT
Also known as: tomography, computed
Correlative studies
Change in standardized uptake value (SUV) uptake after gallium Ga 68-edotreotide
The endpoint is a binary outcome (+ or -) of SUV uptake (after gallium Ga 68-edotreotide) and a binary outcome confirmed at biopsy (+ or -).
Time frame: Baseline up to 30 days
Proportion of discordance and concordance between gallium Ga 68-edotreotide and biopsy
Time frame: Up to 30 days
This study is withdrawn, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Sue O'Dorisio