Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma

NCT03168919 | Terminated Results FDA Device

• 1 other identifier: F160324004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to determine if quantitative imaging techniques can be used to detect dynamic changes of morphology and different physiologic properties of the tumor during and after completion of radiation treatment and to predict site and time of radiation.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Changes of the Chemical Environment of the Tumor

  Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.

  From Baseline to 6 weeks.

Secondary Outcomes (3)

• Changes of Tumor Cellularity

  From baseline to 6 weeks

• Changes of Tumor Volume

  From baseline Up to 6 weeks

• Changes of Tumor Angiogenesis

  From baseline to 6 weeks

Other Outcomes (1)

• Time to Progression

  From Baseline through 24 months.

Study Arms (1)

Chemoradiation with MRI assessment

EXPERIMENTAL

This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group.

Radiation: Fractionated Radiation; Drug: Temozolomide; Device: MRI

Interventions

Fractionated Radiation RADIATION

Standard of care fractionated radiation therapy will be given to the tumor.

Chemoradiation with MRI assessment

Temozolomide DRUG

Standard of care temozolomide will be given along with radiation therapy

Also known as: Temodar

Chemoradiation with MRI assessment

MRI DEVICE

Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.

Also known as: Multi parametric MRI including MR spectroscopy

Chemoradiation with MRI assessment

Eligibility Criteria

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

You may qualify if:

• Newly diagnosed glioma, based on pathology confirmation;
• At least 8 cm3 of residual enhancing tumor after surgery or significant visible tumor (As seen on immediate postoperative scan);
• Scheduled to receive standard fractionated RT with concomitant temozolomide therapy;
• Karnofsky Performance Score \> 60.

You may not qualify if:

• Scheduled to receive investigational chemotherapy, immunotherapy, or any other investigational agents;
• Placement of GLIADEL® wafer in the resection cavity;
• Significant amount of hemorrhage within the resection cavity (seen on immediate post-operative scan);
• A large peritumoral infraction related to surgery (identified by new confluent diffusion restriction);
• Not suitable to undergo MRI or use the MRI contrast agent (GFR\<30 mL/min/1.73 m2); or the patient has known anaphylactic reaction to gadolinium based contrast agents.
• Presence of serious systemic illness, including: uncontrolled infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might impact the survival endpoint of the study or limit compliance with study requirements.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study enrollment was much less than anticipated. With only 5 subjects in the study, it is difficult to make a meaningful conclusion.

Results Point of Contact

• Title: Asim K. Bag, MD Bag
• Organization: St. Jude Children's Reaserch Hospital

asim.bag@stjude.org

9015953347

Study Officials

• Asim Bag, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: One arm study

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 30, 2017
• Study Start: October 6, 2016
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: October 1, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)