Evaluating Therapeutic Response to Novo-TTF

NCT02441322 | Completed

• 2 other identifiers: 12314820817
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the utility of high resolution 3D echo planar magnetic resonance spectroscopy (3D EPSI) in monitoring Novo-TTF response in glioblastoma multiforme (GBM) patients.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Radiological response using standard of care bi monthly MRI scans

  MRI scans will be used to help track radiological response to Optune therapy

  up to 2 years

Secondary Outcomes (3)

• Overall survival (OS)

  up to 2 years

• Progression free survival time

  up to 2 years

• Treatment Response using modified RANO criterion

  up to 2 years

Study Arms (1)

Methods to identify treatment response

EXPERIMENTAL

The investigators will study how well these advanced MRI methods are in accurately identifying response to Novo-TTF in comparison to standard MRI methods for evaluation of treatment response. Using advanced MRI imaging techniques may help assess treatment response earlier than changes in tumor volume which can be measured with standard MRI methods.

Device: Novo-TTF

Interventions

Novo-TTF DEVICE

Procedures: MRI and advanced MRI sequence Advanced brain MRI's with special sequences will be obtained. First MRI prior to starting Novo-TTF therapy, second MRI up to 2-3 weeks after beginning therapy, third MRI up to 2 months from starting treatment and the last MRI up to 4 months after starting treatment.

Also known as: Optune

Methods to identify treatment response

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed or recurrent GBMs
• Received maximal debulking surgery and radiotherapy (protons or photons) concomitant with Temozolomide (40-75Gy)
• Patients may enroll in the study if received Gliadel wafers before entering the trial.
• Minimal dose for concomitant radiotherapy is 40 Gy
• Karnofsky scale of 60 or greater
• Life expectancy at least 3 months
• Must sign written informed consent
• Treatment start date at least 4 weeks out from surgery or as soon as skin healing/radiation reaction allows
• Measurable enhancing neoplasm on post contrast T1 weighted images and/or non enhancing FLAIR signal abnormality

You may not qualify if:

• Actively participating in another clinical treatment trial
• Pregnant
• Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
• Thrombocytopenia (platelet count less than 100 x 1000 per microlitre)
• Neutropenia (absolute neutrophil count less than 1.5 x 1000 per microlitre)
• CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
• Significant liver function impairment AST or ALT 3 times the upper limit of normal
• Total bilirubin upper limit of normal
• Significant renal impairment (serum creatinine greater than 1.7 mg/dL)
• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
• Infra-tentorial tumor
• Evidence of increased intracranial pressure (midline shift 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Suyash Mohan, Dr.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: May 12, 2015
• Study Start: December 1, 2014
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

US (1)