Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT00376103
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed, unifocal, unilateral, supratentorial lesion seen on MRI and suspicious for Glioblastoma Multiforme
* Subject must be a candidate for surgical resection of the tumor mass with feasible gross total resection
* Age 18 years or older
* Subject must be an appropriate candidate to receive brachytherapy and temozolomide per the GliaSite RTS and temozolomide IFU
* The tumor must be histopathologically confirmed by intra-operative frozen section and by final pathology
* Karnofsky Performance Status (KPS) =\> 70
* Negative pregnancy test if a female of childbearing age and not surgically sterilized
* Male or female subject agrees to use acceptable birth control methods while receiving treatment (if not surgically sterile)
* Life expectancy \> 3 months
* Adequate laboratory results: ANC =\> 1.5 x 109/L. Platelets =\> 100 x 109/L
* Subject or legal representative must provide informed consent and HIPAA authorization prior to surgery
Exclusion Criteria:
* Prior use of temozolomide
* Presence or history of severe hepatic or renal impairment
* Subject cannot tolerate temozolomide therapy due to NPO status or intractable nausea and vomiting
* Subject with prior intracranial malignancy
* Major medical illness or psychiatric impairments that in the investigators opinion will prevent administration or completion of the protocol therapy
* Subject has pacemaker or other MRI non-compatible metal in the body
* Previous radiation to the head/neck or brain
* Pregnant or lactating women
* Patient has allergy to iodine and/or dacarbazine
* Creatinine \> 1.5x upper limits of normal (ULN), AST \> 3x ULN
* Chemotherapy within the last 6 months
* Residual tumor \>1 cm (in a single dimension) on baseline MRI scan (T1 post-gadolinium images)
* Balloon surface within 1 cm of critical structure (brain stem, midbrain, optic chiasm) on baseline MRI scan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00376103
Study Brief:
Protocol Section:
NCT00376103