Multiparametric MRI as a Non-Invasive Biomarker of the Tu... | NCT04803084

Studies
Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment

NCT04803084

Sponsor

Laura Kennedy

Status

Suspended

Last Update Posted

Nov 20, 2024Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Breast Cancer
Triple-negative Breast Cancer

Interventions

Tempus assay
Advanced pathology 1
Advanced pathology 2

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50CA098131	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

MRI upgrade

Expanded Access Info

Start Date

Aug 9, 2021Actual

Primary Completion Date

Aug 2025Estimated

Completion Date

Aug 2025Estimated

First Submitted Date

Mar 12, 2021

First Submission Date that Met QC Criteria

Mar 12, 2021

First Posted Date

Mar 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2024

Last Update Posted Date

Nov 20, 2024Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.

Detailed Description

Primary Objective:

- To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent

Secondary Objective:

To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
To assess the prognostic potential of MRI features

Correlative:

To correlate MRI features with immunophenotypes (i.e. hot and cold tumors)
To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Advanced Pathology		Breast magnetic resonance imaging (MRI) as a preliminary predictive biomarker for breast cancer treatment response.	Other: Tempus assay Other: Advanced pathology 1 Other: Advanced pathology 2

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tempus assay	Other	Blood collection	Advanced Pathology
Advanced pathology 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlate dynamic-contrast enhanced MRI characteristics		Baseline up to about 14 weeks
Correlate diffusion weight imaging MRI characteristics		Baseline up to about 14 weeks

Secondary Outcomes

Measure	Description	Time Frame
Evaluate association between MRI features and pathologic response		Baseline up to about 14 weeks
Evaluate association between MRI features and recurrence-free survival		Baseline up to about 14 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women and men at least 18 years of age.

Have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only
Hormone receptor negative (estrogen-receptor < 5% and/or progesterone-receptor < 5%)
Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
Enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study
Planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider
Have tissue available for additional correlative studies OR planned to undergo an additional pre-treatment biopsy for additional tissue acquisition as per provider or the treatment clinical trial
Be a candidate for MRI imaging.
Be willing to comply with scheduled visits required for the trial.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast MRI.

Poor visualization of the tumor on the initial breast MRI (investigator discretion)
Pregnant or nursing.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women and men at least 18 years of age that have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only.

Sampling Method

Non-Probability Sample

ID	Term
D001943	Breast Neoplasms
D064726	Triple Negative Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases