Is NCT05303467 recruiting in Baltimore, MD?

Yes, NCT05303467 is currently recruiting participants at its Baltimore, MD location. This glioblastoma multiforme clinical trial is actively enrolling qualified participants.

How do I join the glioblastoma multiforme clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Glioblastoma Multiforme Clinical Trial in Baltimore, MD

Who Can Participate

Inclusion Criteria

Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)

Life expectancy ≥ 12 weeks

Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule

History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria

Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria

Prior surgery and treatment with combination of radiotherapy and chemotherapy ± Tumor Treating Fields (Optune®)

Prior cranial radiation dose \< 66 Gy

WHO performance status ≤ 2

The interval since completion of cranial radiotherapy must be \> 6 months, unless there is tissue confirmation of tumor recurrence/progression outside the previous radiation treatment field, in which case the interval since completion of cranial radiation must be at least 12 weeks

Interval since last systemic therapy until presumed date of intervention ≥ 1 cycle or ≥ 2 biological half-lives, i.e.

≥ 4 weeks since last dose of temozolomide

≥ 6 weeks since last dose of lomustine or other nitrosourea

≥ 2 weeks since last dose of a small molecule targeted agent (Tyrosine Kinase Inhibitor or similar)

≥ 6 weeks from last dose of last intravenous bevacizumab infusion, or other antibody-based VEGF therapy

If receiving steroids, patient should be on a stable or decreasing dose equivalent to dexamethasone ≤ 6 mg/d, for at least 7 days prior to registration

Have adequate organ and bone marrow function within 14 days prior to registration, as defined below:

INR ≤ 1.2 (in absence of anticoagulation)

Platelets ≥ 100,000/L

Creatinine ≤1.5 mg/dL

Absolute Neutrophil Count ≥1.5 x 10\^9/L

Hemoglobin ≥9.0 g/dL

Have a negative pregnancy test within 14 days prior to registration on study (for FOCBP, female of child-bearing potential)

Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically acceptable method of birth control as confirmed by the investigator

Angiographic Mapping Inclusion Criteria:

Accessible neurovascular anatomy that allows for safe microcatheter placement (up to two locations) to infuse TheraSphere GBM to treat all of the T1 enhancing component of target lesion confirmed by neuro-interventional team.

Total treatment volume is ≤ 150cc as determined by multidisciplinary team.

Additional Inclusion Criteria:

Group A: perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain

Group B: perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain

Group C: perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain

Group D: perfused volume encompasses the dominant hemisphere and eloquent regions of the brain

Exclusion Criteria

Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain, brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor approximating or invading the brainstem and/or optic chiasma, leptomeningeal disease, or extracranial metastatic disease

Have received more than 1 course of prior cranial radiotherapy (EBRT)

Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy

Have received more than 2 systemic treatment protocols (lines of treatment), not including maintenance temozolomide

Have received prior intra-arterial cerebral infusion therapy

Have received more than 2 surgical GBM-related procedures

Have received prior thoracic radiation therapy

Are at increased risk of wound dehiscence by the discretion of the investigators (e.g. brain surgery within the last 3 months, poor skin condition, and/or previously infected surgical field or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)

Have uncontrolled epilepsy

Have severe and/or insufficiently controlled intercurrent illness; patients with the following are not eligible:

Hypertension grade 3 or higher without adequate control on medications

Symptomatic or unstable cardiac disease, known to have right-to-left shunts, or severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg)

Pulmonary insufficiency (arterial oxygen pressure (Pa,O2) of \< 60 mmHg, or oxygen saturation (Sa,O2) of \< 90%) as measured by fingertip pulse oximeter

Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)

Pneumonitis

Psychiatric illness/social situations that would limit compliance with study requirements

Peripheral Neuropathy ≥ grade 1

Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety, study endpoints or longevity

Are currently pregnant or breast feeding (unless patient agrees to stop breastfeeding)

Patients with a history of an active other malignancy within 1 year prior to registration. NOTE: Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease, or recurrent glioblastoma

Patients with a history of ischemic cerebral disease and/or at risk of cerebral herniation

Medical contraindication to undergo contrast-enhanced magnetic resonance imaging (MRI)

Known history of hypersensitivity reactions to iodinated and/or gadolinium-based contrast

Subject has received any other investigational agents within 4 weeks of treatment, or is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team)

Angiographic Mapping Exclusion Criteria: Patients with significant vascular disease, significant AV shunting, or anatomic tortuosity on MR/CT Angiogram precluding safe or feasible vascular access

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT05303467) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Glioblastoma Multiforme Treatment Options in Baltimore, MD

If you're searching for glioblastoma multiforme treatment options in Baltimore, MD, this clinical trial (NCT05303467) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this clinical trial. You'll receive care from experienced glioblastoma multiforme specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all glioblastoma multiforme clinical trials near you to find additional studies recruiting in your area.

Glioblastoma Multiforme Clinical Trial in Baltimore, MD

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