Imaging With [11C]Martinostat in Breast Cancer

NCT03721211 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 17-447
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying a PET imaging tracer as a possible means of imaging breast cancer. The imaging agent involved in this study is:

• \[11C\]Martinostat (called C-eleven-Martinostat)

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PET-MRI Visualization and Quantification of Breast Tumor Uptake of [11C]Martinostat Above Background Uptake, as Assessed by SUV Measurements

  Evaluate the ability of PET-MRI to visualize and quantify uptake of \[11C\]Martinostat in breast tumors above background tracer uptake. SUVmax will be collected from the primary breast tumor and the normal background breast tissue. The study is powered to detect a difference in mean background SUVmax of 0.4 in breast parenchyma uninvolved by tumor and breast parenchyma with breast tumor using a two-sample t-test.

  up to 2 years

Secondary Outcomes (4)

• Quantitative [11C]Martinostat-PET Uptake in Primary Breast Cancer, and Correlation with Expression of HDAC Isoforms

  up to 2 years

• Correlation of Total Volume of Distribution of Dynamic [11C]Martinostat Uptake with Expression of HDAC Isoforms

  up to 2 years

• Comparison of HDAC Isoform Expression by Western Blot Across Breast Tumor Subtypes

  up to 2 years

• HDAC Expression Levels in Breast Tumors Compared to HDAC Expression in Adjacent Normal Breast Parenchyma

  up to 2 years

Study Arms (1)

[11C]Martinostat

EXPERIMENTAL

* Subjects will be administered \[11C\]Martinostat, which is synthesized on site at the MGH Martinos Imaging Center * All subjects will undergo an MR-PET scan of the thorax, including the breasts, to determine tumor uptake * All subjects will be scanned using \[11C\]Martinostat during an imaging session on a Siemens Biograph mMR integrated MR-PET scanner * PET imaging will begin concomitant with radiotracer administration

Drug: [11C]Martinostat; Device: MR-PET scanner

Interventions

[11C]Martinostat DRUG

a type of dye used for radiographic imaging of the HDAC protein

Also known as: Martinostat

[11C]Martinostat

MR-PET scanner DEVICE

PET, or positron emission tomography, is a type of imaging test that uses a tracer, or dye, to make detailed pictures showing the activities of the cells that make up tissues and organs

[11C]Martinostat

Eligibility Criteria

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

You may qualify if:

• Be at least 18 years or age (required for legal consent)
• Have ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
• Have breast imaging findings from mammogram, ultrasound, or breast MRI that are highly suspicious (i.e. coded as BI RADS 5) for breast cancer.
• Have primary breast tumor that is at least 2 cm in diameter as measured in any dimension on either mammogram, ultrasound, or breast MRI
• Have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Previously treated breast cancer
• Concurrent malignancy of any type
• Recent breast surgery (within the past 12 months) on the ipsilateral breast as the current breast tumor
• Impaired elimination (as defined as having problems with urination)
• Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan
• Participation in a research study/studies involving radiation exposure within the past 12 months
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, major kidney or liver disease, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnancy
• Currently lactating (either breast feeding or breast pumping)
• Pregnant women are excluded from this study because of the radioactivity of \[11C\]Martinostat and the resulting risks of teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of \[11C\]Martinostat, and because lactation may potentially affect the uptake of \[11C\]Martinostat on PET, breastfeeding women are excluded from the study.
• Electrical implants such as cardiac pacemakers or perfusion pumps
• Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing
• Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
• Inability to lie comfortably on a bed inside a PET camera for 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis)
• Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure for female subjects of child-bearing age.

Sponsors & Collaborators

• Christine Elizabeth Edmonds: lead

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02214, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

martinostat

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christine E Edmond, MD

  Massachusetts General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: October 26, 2018
• Study Start: February 1, 2020
• Primary Completion: February 28, 2020
• Study Completion: October 31, 2024
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)