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Male Breast CancerNCT01931709

FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer

A study testing fludeoxyglucose F 18, positron emission tomography and dynamic contrast-enhanced magnetic resonance imaging in people with Male Breast Cancer and Stage II Breast Cancer, run by University of Washington at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
fludeoxyglucose F 18, positron emission tomography and dynamic contrast-enhanced magnetic resonance imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Nov 2011to 26 Oct 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
  • Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven)
  • No obvious contraindications for primary chemotherapy
  • Able to lie still for PET and MRI scanning
  • Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Who cannot join

  • Serious systemic illness other than breast cancer
  • Contraindication to MRI or history of adverse reaction to gadolinium
  • Evidence of distant disease outside of regional lymph nodes
  • Pregnant
  • Poorly controlled diabetes mellitus (fasting blood glucose > 200)
  • Prior systemic cancer therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Quantitative Dynamic PET and MRI and Breast Cancer Therapy

This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine whether detailed kinetic analysis of FDG PET and magnetic resonance (MR) imaging studies for measures of tumor metabolism and blood perfusion can predict response and outcome for breast cancer patients undergoing neo-adjuvant therapy.

II. To compare the in vivo tumor biology associated with responsive and resistant tumors as measured by kinetic changes in FDG PET and MR imaging parameters to tumor subtypes analyzed from assay of pre-therapy biopsy and post-therapy surgical tissue.

OUTLINE:

Patients undergo FDG PET and DCE-MRI 1-2 weeks before prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).

Being tested
fludeoxyglucose F 18, positron emission tomography, dynamic contrast-enhanced magnetic resonance imaging, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms, Male, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fludeoxyglucose F 18Radiation

    Also called 18FDG, FDG

    Undergo FDG PET

  • positron emission tomographyDevice

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Undergo FDG PET

  • dynamic contrast-enhanced magnetic resonance imagingDevice

    Also called DCE-MRI

    Undergo DCE-MRI

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01931709
Study groupRoleWhat they receive
Diagnostic (FDG PET and DCE-MRI)ExperimentalPatients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
Receives: Radiation: fludeoxyglucose F 18; Device: positron emission tomography; Device: dynamic contrast-enhanced magnetic resonance imaging; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Favorable Pathologic Response at Surgery

    The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as:

    1. No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0)
    2. Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)

    Measured: At time of surgery

Secondary outcomes (5)

  1. Percent Change in PET K1 Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response

    Percent change in tumor perfusion between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.

    Measured: Baseline to up to 12 weeks (mid-therapy)

  2. Percent Change in Tumor Metabolism / Perfusion Ratio (MRFDG/K1) Between Mid-therapy and Pre-therapy FDG PET Scans and Its Association With Pathologic Response

    Percent change in tumor metabolism / perfusion ratio between pre-therapy and mid-therapy FDG PET scans as represented by the PET measure MRFDG/K1 (parametric) % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.

    Measured: Baseline to up to 12 weeks (mid-therapy)

  3. Time From Surgery to Breast Cancer Recurrence

    Mean (range)

    Measured: The time from surgery to breast cancer recurrence. If recurrence does not occur during follow-up, the endpoint will be censored at the time of last documented disease-free status.

  4. Time of Surgery to Overall Survival

    Mean (range)

    Measured: Overall survival from time of surgery. If death does not occur during follow-up, the endpoint will be censored at the date of last contact when the patient was verified as alive.

  5. Percent Change in DCE-MRI Peak Percent Enhancement (Peak PE) Between Mid-therapy and Pre-therapy Breast MRI Scans and Its Association With Pathologic Response

    Percent change in tumor enhancement between pre-therapy and mid-therapy DCE-MRI scans as represented by the MRI measure Peak PE % change: (Mid-Pre)/Pre, compared between groups of patients who did or did not achieve favorable pathologic response.

    Measured: Baseline to up to 12 weeks (mid-therapy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2013 (estimated)
  2. Study startNov 2011
  3. Primary completionFeb 2016
  4. Study completion26 Oct 2022

Why it stopped: Terminated due to end of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931709
Sponsor's protocol ID
7587
Other IDs
NCI-2013-01668, 7587, P30CA015704, P50CA138293, RG1712020
Status last verified
Oct 2023
First submitted
26 Aug 2013
Last updated
18 Nov 2023
Data monitoring committee
No

Publications

  • Kazerouni AS, Peterson LM, Jenkins I, Novakova-Jiresova A, Linden HM, Gralow JR, Hockenbery DM, Mankoff DA, Porter PL, Partridge SC, Specht JM. Multimodal prediction of neoadjuvant treatment outcome by serial FDG PET and MRI in women with locally advanced breast cancer. Breast Cancer Res. 2023 Nov 9;25(1):138. doi: 10.1186/s13058-023-01722-4.

    PubMed 37946201

Questions about this trial

What is this clinical trial studying?

A study testing fludeoxyglucose F 18, positron emission tomography and dynamic contrast-enhanced magnetic resonance imaging in people with Male Breast Cancer and Stage II Breast Cancer, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Favorable Pathologic Response at Surgery (time frame: At time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01931709, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.

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