Breast CancerNCT01892540

PET/CT or PET/MRI in Measuring Tumors in Patients Undergoing Clinical Imaging or With Newly Diagnosed Breast Cancer

A study testing positron emission tomography/computed tomography, PET/MRI and Position Device in people with Breast Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
What is being tested?: positron emission tomography/computed tomography, PET/MRI and Position Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: May 2013to Jun 2015
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

[Cohorts 1 and 2] Female patients who are referred by their physician to have a clinical PET/CT
[Cohort 3] Patients referred for clinical breast dynamic contrast-enhanced (DCE)-MRI for recently diagnosed breast cancer
Normal kidney function for subjects that will receive magnetic resonance (MR) contrast agent as part of their clinical imaging
For subjects for whom MR contrast agent is to be administered, University Hospitals (UH) policy 8.17.26 will be applied
The following guidelines will be followed when a patient or patient representative responds "yes" to questions on the MRI history sheet 'Are you on dialysis, history of kidney failure, end stage renal disease, chronic liver disease, or are you a peri-liver transplant patient':
The patient must have a serum creatinine value available within three (3) weeks prior to the injection of gadolinium

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Calculate an estimated glomerular filtration rate (eGFR) based on serum creatinine; if the eGFR is less than 30 the attending radiologist must discuss the risks and benefits of administering gadolinium with the referring physician and patient; the collective judgment of the patient, radiologist and referring physician must be in agreement to proceed with the injection of gadolinium
Calculated eGFR in range of 31-59 requires the judgment of the attending radiologist whether to discuss gadolinium administration with referring physician and patient or whether to directly use or hold the contrast agent
If an eGFR is greater than 60, gadolinium may be administered without further physician or patient discussion
Gadolinium administration is limited to single dose at 0.1mmol/kg; Omniscan should not be used
Technologist will document radiologist decision to administer gadolinium on the MRI history sheet; radiologist will document decision and consultation with the referring physician and patient in the MRI report
PERITONEAL DIALYSIS PATIENTS:
No gadolinium will be administered unless the patient has been scheduled for hemodialysis within 24 hours following the injection of gadolinium; technologist will determine eGFR and follow above guidelines; dialysis will be scheduled by the referring physician
HEMODIALYSIS PATIENTS:
No gadolinium will be administered unless the patient has been scheduled for hemodialysis within 24 hours following the injection of gadolinium; no determination of eGFR is necessary; radiologist will assume eGFR less than 30 and follow above guidelines; dialysis will be scheduled by the referring physician
Ability to provide informed consent

Who cannot join

Subjects who do not meet all of the above inclusion criteria
Subjects unwilling or unable to sign the informed consent form
Subjects who are cognitively impaired and thus unable to give informed consent
Subjects unable to undergo MR scanning due to exclusion via University Hospitals Case Medical Center (UHCMC) MR restrictions (e.g. certain implanted metallic or electronic devices)
Subjects who are pregnant
Subjects that are too large to fit comfortably into the PET/MR on the breast coil; for cohort 1 only we will accept a maximum of 10 subjects that are too large for the PET/MRI to acquire a prone PET/CT but without the paired PET/MR

Trial locations and contacts

1 site in 1 country.

United States1 site

Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

Official title: Positron Mammographic Imaging (PMI)

This clinical trial studies positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer. New diagnostic procedures, such as PET/CT or PET/MRI, may be more effective than MRI alone in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer.

Read the detailed description

PRIMARY OBJECTIVES:

To improve visualization of tumors by developing better image reconstruction and correction methods.

II. To revise the positioning devices and, if necessary, scanner table to fit a wider size range of women.

OUTLINE:

Patients undergo clinical fludeoxyglucose F-18 (FDG)-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without gadopentetate dimeglumine (DTPA).

Conditions: Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Being tested: positron emission tomography/computed tomography, PET/MRI, Position Device
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 tomography/computed tomographyDiagnostic test
Undergo PET/CT
PET/MRIDiagnostic test
Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position DeviceDevice

Study groups in NCT01892540
Study group	Role	What they receive
Cohort 1: Standard positioning device	Experimental	Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA. Receives: Diagnostic Test: positron emission tomography/computed tomography; Diagnostic Test: PET/MRI
Cohort 2: New positioning device	Experimental	Not described Receives: Diagnostic Test: positron emission tomography/computed tomography; Diagnostic Test: PET/MRI; Device: Position Device
Cohort 3: Current positioning device until new is available	Experimental	Not described Receives: Diagnostic Test: positron emission tomography/computed tomography; Diagnostic Test: PET/MRI; Device: Position Device

What is being measured

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

Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II)
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
Measured: 1 yr from study start
Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II)
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
Measured: 1 yr from study start
Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)
McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare specificity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest specificity. Single parameter: DCE-MRI is the gold standard to which the two parameter and three parameter rows are compared.
Combinations include:
Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET
Measured: 1 yr from study start
Sensitivity of PET/CT and PET/MRI (Cohort III)
McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare sensitivity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest sensitivity.
Combinations include:
Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET
Measured: 1 yr from study start

Timeline

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

May 2013Jun 2015

First posted4 Jul 2013 (estimated)
Study startMay 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01892540
Sponsor's protocol ID: CASE15112
Other IDs: NCI-2013-00938, PMI TECH 12-050
Status last verified: Feb 2020
First submitted: 1 Jul 2013
Last updated: 4 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Positron Mammographic Imaging (PMI)
ClinicalTrials.gov ID: NCT01892540
Acronym / sponsor ID: CASE15112
Conditions: Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: May 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 4 Jul 2013 (estimated)
Results: Posted 25 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To improve visualization of tumors by developing better image reconstruction and correction methods.

II. To revise the positioning devices and, if necessary, scanner table to fit a wider size range of women.

OUTLINE:

Patients undergo clinical fludeoxyglucose F-18 (FDG)-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without gadopentetate dimeglumine (DTPA).

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1: Standard positioning device	Experimental	Diagnostic Test: positron emission tomography/computed tomography, Diagnostic Test: PET/MRIPatients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.
Cohort 2: New positioning device	Experimental	Diagnostic Test: positron emission tomography/computed tomography, Diagnostic Test: PET/MRI, Device: Position Device
Cohort 3: Current positioning device until new is available	Experimental	Diagnostic Test: positron emission tomography/computed tomography, Diagnostic Test: PET/MRI, Device: Position Device

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

[Cohorts 1 and 2] Female patients who are referred by their physician to have a clinical PET/CT
[Cohort 3] Patients referred for clinical breast dynamic contrast-enhanced (DCE)-MRI for recently diagnosed breast cancer
Normal kidney function for subjects that will receive magnetic resonance (MR) contrast agent as part of their clinical imaging
For subjects for whom MR contrast agent is to be administered, University Hospitals (UH) policy 8.17.26 will be applied
Ability to provide informed consent

Key exclusion criteria (6 listed)

Subjects who do not meet all of the above inclusion criteria
Subjects unwilling or unable to sign the informed consent form
Subjects who are cognitively impaired and thus unable to give informed consent
Subjects unable to undergo MR scanning due to exclusion via University Hospitals Case Medical Center (UHCMC) MR restrictions (e.g. certain implanted metallic or electronic devices)
Subjects who are pregnant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
positron emission tomography/computed tomographyUndergo PET/CT	Diagnostic test	Cohort 1: Standard positioning device, Cohort 2: New positioning device, Cohort 3: Current positioning device until new is available
PET/MRIUndergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging	Diagnostic test	Cohort 1: Standard positioning device, Cohort 2: New positioning device, Cohort 3: Current positioning device until new is available
Position Device	Device	Cohort 2: New positioning device, Cohort 3: Current positioning device until new is available

Primary outcome

Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II)
Time frame: 1 yr from study start
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II)
Time frame: 1 yr from study start
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)
Time frame: 1 yr from study start
McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare specificity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest specificity. Single parameter: DCE-MRI is the gold standard to which the two parameter and three parameter rows are compared. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET
Sensitivity of PET/CT and PET/MRI (Cohort III)
Time frame: 1 yr from study start
McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare sensitivity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest sensitivity. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET

Results and safety

Results posted to the registry on 25 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1: Standard Positioning Device	15	15
Cohort 2: New Positioning Device	0	0
Cohort 3: Current Positioning Device Until New is Available	28	25

Primary outcome: Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II)

Time frame: 1 yr from study start

Population analysed: No data available - SUV data do not exist for Cohort I and cohort II was never conducted.

Primary outcome: Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II)

Time frame: 1 yr from study start

Population analysed: No data available - SUV data do not exist for Cohort I and cohort II was never conducted.

Primary outcome: Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)

Time frame: 1 yr from study start. Mean (Full Range). Unit: percent of specificity

Measure	Cohort 1: Standard Positioning Device n = 0	Cohort 2: New Positioning Device n = 0	Cohort 3: Current Positioning Device Until New is Available n = 25
Single parameter: DCE-MRI	–	–	0 (0 to 0)
Two Parameter A: DCE-MRI and DWI ADC	–	–	89 (52 to 100)
Two Parameter B: DCE-MRI and FDG-PET	–	–	89 (52 to 100)
Three Parameter: DCE-MRI, DWI ADC, FDG-PET	–	–	100 (66 to 100)

Population analysed: Participants in cohort 3 that completed scans.

Primary outcome: Sensitivity of PET/CT and PET/MRI (Cohort III)

Time frame: 1 yr from study start. Mean (Full Range). Unit: percent sensitivity

Measure	Cohort 1: Standard Positioning Device n = 0	Cohort 2: New Positioning Device n = 0	Cohort 3: Current Positioning Device Until New is Available n = 25
Single parameter: DCE-MRI	–	–	100 (100 to 100)
Two Parameter A: DCE-MRI and DWI ADC	–	–	95 (83 to 100)
Two Parameter B: DCE-MRI and FDG-PET	–	–	86 (71 to 100)
Three Parameter: DCE-MRI, DWI ADC, FDG-PET	–	–	85 (70 to 94)

Population analysed: Participants in cohort 3 that completed scans.

Adverse events

Time frame: Adverse vents and other safety parameters monitored throughout study for up to 1 yr from study start. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1: Standard Positioning Device	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Cohort 2: New Positioning Device	0 of 0	0 of 0	0
Cohort 3: Current Positioning Device Until New is Available	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Limitations and caveats (from the sponsor): Cohort 1 was not completed (15 of 40 participants) and cohort 2 was not collected because of recruitment issues. Imaging data was collected for available participants but SUV data were not collected from images due to low recruitment

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Donna Plecha, MD principal investigator

Case Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: finished, as of the sponsor's last update on 4 Mar 2020. 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 25 Feb 2020). 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?

Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II) (time frame: 1 yr from study start). The study lists 4 primary outcomes in all. 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 NCT01892540.

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 4 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.