An Early Phase Clinical Trial to Evaluate the Feasibility... | NCT02380209

Studies
An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer

NCT02380209

Sponsor

University of Arizona

Status

Terminated

Last Update Posted

Oct 27, 2016Estimated

Enrollment

8Actual

Phase

Early Phase 1

Conditions

Breast Cancer

Interventions

CEST MRI

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI has terminated study as the sequencing on patients and volunteers didn't yield the results expected. PI has no plans for scholarly/scientific presentations.

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jan 9, 2015

First Submission Date that Met QC Criteria

Mar 4, 2015

First Posted Date

Mar 5, 2015Estimated

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

Oct 25, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe) to a clinical MRI scanner in women with early stage breast cancer. Assays are used to quantify tumor acidosis.

Detailed Description

Those involved in the treatment of patients with breast cancer have pioneered the field of personalized cancer therapy through the use of targeted therapies and their associated biomarkers. Assays to quantify tumor acidosis and hypoxia are hypothesized to potentially represent such biomarkers. However there is currently no gold standard for measuring either.

This trial will evaluate the feasibility of translating preclinical Chemical Exchange Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe), to a clinical MRI scanner in women with early stage breast cancer. This trial will generate preliminary data regarding the feasibility of this imaging technique. If successful, in future studies CEST MRI may serve as an imaging biomarker for acidosis and hypoxia.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Optimization	Experimental	CEST MRI of the breast for estimation of tumor pH.	Other: CEST MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CEST MRI	Other	CEST MRI will be performed on patients prior to surgical resection of their tumor	Optimization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pH measurement of the tumor will be measured by the CEST MRI.	pH estimate of the tumor	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Correlate tumor pH as estimated by CEST MRI with protein and RNA based markers for acidosis and hypoxia.		2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast
>= 1.0 cm primary tumor
Calculated creatinine clearance >= 50 mL/min
Willing and able to provide informed consent
Age ≥ 18 years
ECOG performance status 0-2
Informed of the investigational nature of this study

Exclusion Criteria:

Allergy to iodinated contrast agent
Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of NSAIDs
Diabetes mellitus
History of severe claustrophobia
Presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude MRI
Use of > 1 antihypertensive drug
Pregnancy or breastfeeding
Paraproteinemia syndromes or multiple myeloma
Collagen vascular disease
Active hyperthyroidism
Active pharmaceutical treatments for cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pavani Chalasani, MD	University of Arizona	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Cancer Center at UMC North		Tucson	Arizona	85724	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C038192	iopromide
D007479	Iopamidol

Ancestor Terms

ID	Term
D014283	Triiodobenzoic Acids
D007463	Iodobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic

Browse Leaves

Not provided

Browse Branches

Not provided