Is NCT06039709 recruiting in Charlottesville, VA?

Yes, NCT06039709 is currently recruiting participants at its Charlottesville, VA location. This recurrent glioblastoma clinical trial is actively enrolling qualified participants.

How do I join the recurrent glioblastoma clinical trial in Charlottesville?

To join this clinical trial in Charlottesville, 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 Charlottesville 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.

Recurrent Glioblastoma Clinical Trial in Charlottesville, VA

About This Recurrent Glioblastoma Study in Charlottesville

Patients diagnosed with glioblastoma (GBM) are faced with limited treatment options. This pilot study will evaluate the safety and feasibility of combining an investigational drug called 5-ALA with neuronavigation-guided low-intensity focused ultrasound (LIFU) for patients who have recurrent GBM. Focused ultrasound (FUS) can be used to non-invasively destroy tumor tissue while preserving normal tissue. When FUS is combined with 5-ALA, this combinatorial approach is called sonodynamic therapy (SDT), and this investigational therapy is being tested for its ability to cause damage to GBM cells. SDT will take place prior to surgery for recurrent GBM.

Sponsor: Shayan Moosa, MD

Who Can Participate

Inclusion Criteria

Disease status and Disease Parameters:

Suspected recurrent glioblastoma that is clearly measurable based on the modified Response Assessment in Neuro-Oncology (RANO) criteria

The tumor lesion needs to comprise at least 1 contrast-enhancing lesion with a volume of ≥ 2 cm3 and ≤ 20 cm3 of targeted treatment area

Tumor tissue to be treated is in a surgically accessible brain region for resection

The brain tumor to be treated must be in the treatment envelope of the NaviFUS system (30 mm to 90 mm from the inner skull table)

Recurrence will be assessed by imaging and confirmed by consensus at tumor board

Men or women between the ages of 18-80 years of age at the time of consent

No contraindication to repeat brain surgery

Karnofsky Performance Score of 70-100

Able to undergo an MRI with contrast

Able to swallow oral medications

Willingness and ability to comply with scheduled visits, treatment plans, lifestyle considerations, laboratory tests, and other procedures.

Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).

Participants who received prior chemotherapy, radiation therapy, immunotherapy, and/or another investigational therapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1 or baseline) from the acute effects of the therapy or therapies) except for residual alopecia or Grade 2 peripheral neuropathy prior to registration.

Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility): Hematological

Absolute neutrophil count (ANC) ≥1000/mm3

Platelets ≥ 100,000/mm3

Hemoglobin ≥ 11 g/dL for women and ≥ 12 g/dL for men Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.

INR ≤ 1.4 Renal \& Hepatic

Creatinine clearance CrCl ≥ 60 mL/min/1.73 m2 as estimated by the Cockcroft-Gault (C-G) equation. If estimated CrCl is abnormal, accurate measurement should be obtained by 24- hour CrCl.

Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 2.0x ULN is allowed).

AST and ALT ≤ 3 x ULN

Alkaline phosphatase ≤ 3 x ULN

Estimated glomerular filtration rate ≥30mL/min/1.73m2

Exclusion Criteria

Known sensitivity or allergy to 5-ALA

Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)

Diagnosis of porphyria

Hypersensitivity against porphyrins

Significant cardiac disease or coagulopathy

Herniation / intractable seizure / other clinical indications requiring urgent resection

Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive)

Have had a recent (≤3 months prior to registration) transient ischemic attack or stroke

Significant vascular disease (e.g. aortic aneurysm)

Evidence of bleeding diathesis or coagulopathy

Need for systemic anticoagulation which cannot be held for 7 days prior to SDT

Unstable angina and/or congestive heart failure (NYH Class III or Class IV; see section 13.2) within 6 months prior to registration

Severe hypertension (systolic ≥ 180 mm Hg; diastolic ≥ 120 mm Hg) despite anti-hypertensive medications

Transmural myocardial infarction within 6 months prior to registration

Serious and inadequately controlled cardiac arrhythmia

Acute exacerbation of chronic obstructive pulmonary disease

Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study

Treatment with another investigational drug or investigational procedure within 30 days prior to registration or within 5 half-lives of the investigational product, whichever is longer

Brain edema and/or mass effect that causes midline shift of more than 15 mm

Evidence of recent (within 30 days prior to registration) intracranial hemorrhage

Calcifications or metallic implanted objects in the focused ultrasound sonication path

Scalp atrophy or scars at the expected location of transducer

Cerebral or systemic vasculopathy

Need for or currently on dialysis

Respiratory: chronic pulmonary disorders (e.g., severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area).

Receipt of radiotherapy ≤21 days prior to registration

Receipt of chemotherapy ≤ 21 days prior to registration

Prior treatment with sonodynamic therapy

Concurrent use of Optune device

Concurrent use of supplements or medications with substantial antioxidant effects (including sulfhydryl-containing medications such as captopril or supplements such as N-acetylcysteine, or high doses of vitamins with antioxidant activity such as C or E)

Known sensitivity to gadolinium

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 Charlottesville?

Yes, this clinical trial (NCT06039709) has an active research site in Charlottesville, VA 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.

Recurrent Glioblastoma Treatment Options in Charlottesville, VA

If you're searching for recurrent glioblastoma treatment options in Charlottesville, VA, this clinical trial (NCT06039709) 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 Charlottesville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced recurrent glioblastoma 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 recurrent glioblastoma clinical trials near you to find additional studies recruiting in your area.

Recurrent Glioblastoma Clinical Trial in Charlottesville, VA

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