NovoTTF Treatment Signatures in Glioblastoma Patients At Autopsy

Recruiting

• Conditions: Glioblastoma
• Interventions: Device: Tumor samples from patients treated with TTFields at tumor recurrence.; Other: Tumor samples from patients treated with TTFields at initial diagnosis.

• Registration Number: NCT03194971
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

This study will assess whole brain samples from glioblastoma patients at autopsy to determine the underlying pathological signatures of tumor treatment fields at autopsy.

Detailed Description

RATIONALE:

Optune therapy with tumor treatment fields (TTFields) has recently been FDA approved for the treatment of newly diagnosed glioblastoma due to a recent clinical trial that showed improvement in progression free survival and overall survival compared to standard therapy. (1) TTFields also have a role in the recurrent glioblastoma treatment where it has demonstrated equal efficacy to second-line chemotherapy also has been shown to tumor progression and improve overall survival.(2) Though preclinical studies are ongoing, glioblastoma patients who have undergone TTField therapy have not yet been assessed at autopsy to determine both the pathological signature of TTField treatment, and the pattern of failure. This study will determine how the underlying pathological signatures of tumors treated with TTFields differ from those naïve to TTFields by comparing tumor tissue at autopsy.

STUDY:

All patients undergoing TTField therapy for newly diagnosed and recurrent glioblastoma will be considered for inclusion for this study. The investigators expect to enroll five patients per year for four years, totaling 10 patients treated upfront and 10 patients treated at tumor recurrence. An objective of this study is to determine differences in the pathological pattern of failure when patients are treated with TTFields at initial diagnosis (up-front) compared to those treated at tumor recurrence.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-19
• Study First Posted: 2017-06-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Newly diagnosed glioblastoma, World Health Organization (WHO) grade IV, patients undergoing TTField therapy.
• Recurrent glioblastoma WHO grade IV, patients undergoing TTField therapy.

Exclusion Criteria

• TTField compliance < 75%.
• Any contraindication to Optune TTField treatment.
• Initial brain tumor diagnosis < WHO grade IV.
• Duration of TTField therapy < 3 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TTField at Recurrence	Tumor samples from patients treated with TTFields at tumor recurrence.	-
TTField at New Diagnosis	Tumor samples from patients treated with TTFields at initial diagnosis.	-

Primary Outcome Measures

Name	Time	Method
Number of mitotically active cells	At baseline	Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of active cells will be counted computationally.
Number of mitotically inactive cells	At baseline	Tissue samples will be obtained at autopsy and stained for KI-67. Slides will then be digitized, and the number of not active cells will be counted computationally.
Mitotic Ratio	At baseline	Number of mitotically active cells divided by the number of not mitotically active cells per patient will be calculated.

Trial Locations

Locations (1)

Froedtert & the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States