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Breast CancerPhase 4NCT00484614

Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer

A Phase 4 study testing Positron Emission Mammography and Magnetic Resonance Imaging in people with Breast Cancer, run by Naviscan PET Systems at 6 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). Read more about this study

Who is it for?
Ages 25 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Positron Emission Mammography and Magnetic Resonance Imaging
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
472 participants
Where
6 sitesUnited States
Study dates
Sep 2006to Mar 2009
Phase
Phase 4
Are there results?
None posted in the registry

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 25 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women who are 25 years of age or older
  • Newly diagnosed core-biopsy proven breast cancer
  • Has current mammography of all study breasts (within prior 3 months), including magnification views of suspicious calcifications (if any)
  • Recent clinical breast examination (within prior 3 months)
  • Has had full diagnostic workup with breast ultrasound (within prior 3 months) as indicated by mammographic and/or clinical findings
  • Has had percutaneous biopsy of all relevant suspicious findings on mammography, clinical examination, and ultrasound
Show all 16Show fewer
  • After full diagnostic workup, participant is likely to be a candidate for breast conserving surgery.
  • No contraindications to breast MRI:
  • No pacemaker, aneurysm clip, or other implanted magnetic or ferromagnetic device;
  • No claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative under her physician's orders;
  • Has intravenous access;
  • Weight < 300 lbs;
  • Physically able to tolerate positioning in the MRI scanner.
  • Agrees to undergo follow-up MRI or PEM at 6 months and/or MRI-guided vacuum-assisted biopsy, US-guided core biopsy, or PEM-guided biopsy if needed based on results of the MRI or PEM examination
  • Has signed study-specific consent form
  • Subject agrees to undergo a contrast-enhanced MRI and PEM scan within five business days of each other, prior to surgery.

Who cannot join

  • Male
  • Pregnancy
  • Active lactation or discontinued breastfeeding < 2 months prior
  • Age less than 25 years
  • Inability to provide informed consent
  • Prior radiation treatment to the affected breast(s)
Show all 16Show fewer
  • Participant is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours after the scheduled PEM Flex study
  • Women planning prophylactic mastectomy without histologic confirmation
  • Individuals who are electing to undergo neoadjuvant chemotherapy prior to surgery (Note: Patients with prior contralateral breast cancer receiving chemoprevention with Tamoxifen, Arimidex, or other aromatase inhibitor are eligible)
  • Individuals who have had surgery on the study breast(s) within the past 12 months
  • Breast implant(s) in any study breast(s)
  • Women who have had distant metastatic disease either currently or in the past
  • Individuals with Type I or poorly controlled Type II diabetes mellitus
  • Individuals with a blood glucose level that is above 140 mg/dl at the time of PEM imaging
  • Has not had contrast-enhanced breast MRI or PEM within the past 12 months prior to study enrollment
  • Subject is currently enrolled in another breast imaging research study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Boca Raton Community Hospital

    Boca Raton, Florida, 33486

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 27599

  • University of Southern California

    Los Angeles, California, 90033

  • American Radiology Services, Inc., Johns Hopkins Green Spring

    Lutherville, Maryland, 21093

  • Scripps Cancer Center

    San Diego, California, 92121

Other trials in United States

About this study

Official title: Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer

Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). The purpose of this study is to determine changes in surgical management resulting from PEM or MRI imaging as compared to conventional imaging and to determine if the changes were appropriate with histopathology as gold standard.

Read the detailed description

Breast compression and/or immobilization during positron emission tomographic (PET) imaging has been called positron emission mammography, or "PEM," and the device used to perform the scan has been called a PEM Scanner. This protocol is designed as a prospective multi-center clinical trial to evaluate the role of high resolution PEM, used in combination with the radiotracer 2-[F-18]- fluorodeoxyglucose (FDG), in pre-surgical planning in women with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy) after full workup with mammography, clinical breast exam, and additional US as would normally be performed. Participants will undergo both contrast enhanced MRI and PEM imaging. In order to control for potential bias in interpretation of the second examination (i.e. PEM or MRI), the order of interpretation of these examinations will be randomly assigned at study entry.The primary objective of the study is to determine changes in surgical management resulting from PEM or MRI or both, separately and in conjunction with conventional imaging and to determine whether these changes were appropriate (i.e. to excise malignancy) or inappropriate (e.g. wider excision or mastectomy for what proved to be benign disease).

Conditions
Breast Cancer
Being tested
Positron Emission Mammography, Magnetic Resonance Imaging
Keywords
Breast Cancer, breast conserving surgery
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Positron Emission MammographyProcedure or surgery

    Also called Naviscan PET Systems, PEM Flex Solo

    Molecular Imaging Device

  • Magnetic Resonance ImagingProcedure or surgery

    Imaging Device

Study groups in NCT00484614
Study groupRoleWhat they receive
1 PEMActive comparatorNot described
Receives: Procedure: Positron Emission Mammography
2 MRIActive comparatorNot described
Receives: Procedure: Magnetic Resonance Imaging

What is being measured

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

  1. The primary outcome for this study will be measured by evidence of malignancy on PEM and/or MRI, confirmed by core biopsy or surgery.

    Measured: Within 30 days (plus or minus a week) after core biopsy/surgery

Secondary outcomes (1)

  1. Risk of false positive examinations with either PEM or MRI imaging with surgery as gold standard

    Measured: Within the first 30 days (plus or minus 7 days) after surgery

Timeline

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

  1. First posted11 Jun 2007 (estimated)
  2. Study startSep 2006
  3. Primary completionNov 2008
  4. Study completionMar 2009 (estimated)

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 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
472 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00484614
Sponsor's protocol ID
PEM-06-01
Other IDs
NIH Grant: 5 R44 CA103102-05
Status last verified
Dec 2008
First submitted
8 Jun 2007
Last updated
3 Sep 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Berg WA, Weinberg IN, Narayanan D, Lobrano ME, Ross E, Amodei L, Tafra L, Adler LP, Uddo J, Stein W 3rd, Levine EA; Positron Emission Mammography Working Group. High-resolution fluorodeoxyglucose positron emission tomography with compression ("positron emission mammography") is highly accurate in depicting primary breast cancer. Breast J. 2006 Jul-Aug;12(4):309-23. doi: 10.1111/j.1075-122X.2006.00269.x.

    PubMed 16848840

  • Tafra L, Cheng Z, Uddo J, Lobrano MB, Stein W, Berg WA, Levine E, Weinberg IN, Narayanan D, Ross E, Beylin D, Yarnall S, Keen R, Sawyer K, Van Geffen J, Freimanis RL, Staab E, Adler LP, Lovelace J, Shen P, Stewart J, Dolinsky S. Pilot clinical trial of 18F-fluorodeoxyglucose positron-emission mammography in the surgical management of breast cancer. Am J Surg. 2005 Oct;190(4):628-32. doi: 10.1016/j.amjsurg.2005.06.029.

    PubMed 16164937

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Positron Emission Mammography and Magnetic Resonance Imaging in people with Breast Cancer, run by Naviscan PET Systems at 6 sites 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 16 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 3 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

The primary outcome for this study will be measured by evidence of malignancy on PEM and/or MRI, confirmed by core biopsy or surgery. (time frame: Within 30 days (plus or minus a week) after core biopsy/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 NCT00484614, which also lists 2 linked publications.

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 3 Sep 2009.

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