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Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases

Primary Purpose

Brain Tumor

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MRI

About this trial

This is an interventional diagnostic trial for Brain Tumor focused on measuring Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must have a histologically or cytologically confirmed solid malignancy of extracranial origin and radiographic evidence of at least one brain metastasis for which stereotactic radiation was utilized in the past. Patients with intracranial pathologic confirmation of a malignancy which originated extracranially but for which extracranial disease has not been biopsied are eligible.
Participants must have an enlarging lesion in the brain at least 4 months after prior stereotactic radiation to the same site for which neurosurgical resection is planned as routine standard of care.
Participants must be age 18 years or older.
Participants must be willing to undergo study procedures.
The effects of gadolinium / other MRI-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
Participants must possess the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Participants who have a contraindication to MRI (e.g. non compatible implanted metallic device for which MRI is absolutely contraindicated).
Participants who have chronic kidney disease stage IV-V or end stage renal disease.
Participants with a history of anaphylactic reactions to gadolinium.
Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.

Sites / Locations

Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRAMs I

Arm Description

Magnetic resonance imaging (MRI)-based treatment response assessment maps (TRAMs) Patients with an enlarging lesion in the site of a brain metastasis treated with stereotactic radiation for which neurosurgical resection is planned will undergo preoperative TRAMs

Outcomes

Primary Outcome Measures

Sensitivity

The sensitivity along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review

Secondary Outcome Measures

Specificity

The specificity along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review

Positive predictive value

The positive predictive value along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review

Negative predictive value

The negative predictive value along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review

Full Information

NCT ID

NCT04033497

First Posted

July 24, 2019

Last Updated

September 21, 2023

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT04033497

Brief Title

Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases

Official Title

Treatment Response Assessment Maps (TRAMs) in the Delineation of Radiation Necrosis From Tumor Progression After Stereotactic Radiation in Patients With Brain Metastases: A Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 20, 2019 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This research study is investigating the value of an imaging study of the brain called an MRI (which stands for magnetic resonance imaging), utilized in unique way, to delineate whether the tumor has recurred or whether radiation changes have occurred after a brain metastasis treated with focused radiation has enlarged.

Detailed Description

This research study is a Phase II clinical trial. In this research study, the investigators are utilizing MRIs of the brain with additional post-imaging processing (called Treatment Response Assessment Maps or TRAMs) to try to delineate tumor recurrence from radiation changes. The investigators hope to understand whether such a test may allow future patients to avoid resection entirely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor

Keywords

Brain Tumor

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TRAMs I

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

MRI

Intervention Description

Magnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor.

Primary Outcome Measure Information:

Title

Sensitivity

Description

Time Frame

Within 3 months of study enrollment

Secondary Outcome Measure Information:

Title

Specificity

Description

Time Frame

Within 3 months of study enrollment

Title

Positive predictive value

Description

Time Frame

Within 3 months of study enrollment

Title

Negative predictive value

Description

Time Frame

Within 3 months of study enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants must have a histologically or cytologically confirmed solid malignancy of extracranial origin and radiographic evidence of at least one brain metastasis for which stereotactic radiation was utilized in the past. Patients with intracranial pathologic confirmation of a malignancy which originated extracranially but for which extracranial disease has not been biopsied are eligible. Participants must have an enlarging lesion in the brain at least 4 months after prior stereotactic radiation to the same site for which neurosurgical resection is planned as routine standard of care. Participants must be age 18 years or older. Participants must be willing to undergo study procedures. The effects of gadolinium / other MRI-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Participants must possess the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Participants who have a contraindication to MRI (e.g. non compatible implanted metallic device for which MRI is absolutely contraindicated). Participants who have chronic kidney disease stage IV-V or end stage renal disease. Participants with a history of anaphylactic reactions to gadolinium. Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ayal Aizer, MD, MHS

Phone

617-732-7560

aaaizer@partners.org

First Name & Middle Initial & Last Name or Official Title & Degree

Ivy Ricca, BA

Phone

6175828927

iricca@mgb.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ayal Aizer, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ayal Aizer, MD, MPH

Phone

617-732-7560

aaaizer@partners.org

First Name & Middle Initial & Last Name & Degree

Ayal Aizer, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases

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