PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma

ConditionGlioblastoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJonsson Comprehensive Cancer Center

About this trial

This phase III trial compares pH weighted chemical exchange saturation transfer (CEST) magnetic resonance imaging (MRI)-based surgical resections to standard of care surgical resections for the treatment of patients with glioblastoma. Standard of care therapy for glioblastoma is surgery to remove tumor tissue that enhances on standard MRI imaging, however, it has been shown that significant tumor burden exists in the region around the tumor tissue that does not enhance with standard MRI. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. These pictures can show the difference between normal and tumor tissue. CEST MRI is a technique that uses differences in the tissue environment, like protein concentration or intracellular pH, to generate contrast differences. CEST MRI may identify tumor tissue that does not enhance with standard of care MRI. PH weighted CEST MRI based surgical resection may be more effective compared to standard of care surgical resection in treating patients with glioblastoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female ≥ 18 years of age

Documentation of a newly diagnosed World Health Organization (WHO) grade IV glioblastoma as evidenced by clinical features and imaging data

Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Disqualifiers

Male or female < 18 years of age

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Not medically cleared for surgery

Previous treatment (any chemotherapy, molecular therapy, immunotherapy, or radiation therapy)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemical Exchange Saturation Transfer Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo CEST MRI

  • Contrast-enhanced Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo contrast-enhanced MRI

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Radiation Therapy

    Radiation

    Undergo standard of care radiation therapy

  • Surgical Procedure

    Procedure/Surgery

    Undergo surgical resection

  • Temozolomide

    Drug

    Given PO

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group I (standard of care surgical resection)Active comparator 5 interventions
Group B: Group II (CEST MRI based surgical resection)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Multivariate cox and log rank tests will be used to compare progression free survival.

Time frame
Up to 2 years

Secondary outcomes

1

Overall survival

Multivariate cox and log rank tests will be used to compare overall survival.

Time frame
Up to 2 years
2

Surgical complication rate

Independent sample Chi-squared tests will be used to compare differences in surgical complication rate.

Time frame
Up to 2 years
3

Quality of life: Karnofsky Performance Status

Independent sample Chi-squared tests will be used to compare differences in post-operative Karnofsky performance scale changes. The Karnofsky Performance Status (KPS) is a standardized measure used to assess a patient's ability to perform everyday tasks. It ranges from 0 to 100, with higher scores indicating better function.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: