Breast CancerNCT01031238
Comparison of PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for positron emission tomography (PET) scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Nov 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known or suspected tumors of the breast, 18 years or older scheduled for routine clinical imaging at the PET/CT facility.
Who may be able to join
- A signed informed consent.
- Known or suspected malignancy involving the breast as determined by biopsy, physical examination or noninvasive imaging studies including plain films, CT, MR, ultrasound or nuclear medicine imaging.
- Scheduled for routine clinical imaging at the ACB PET/CT facility.
- Participant must be at least 18 years of age.
Who cannot join
- Uncontrolled blood glucose levels (>200 mg/dl).
- Patient is unable to comprehend the requirements of the study.
- Patient is unable to undergo scanning of the known or suspected lesion with the high-resolution PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Pilot Study to Compare the PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast
The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for positron emission tomography (PET) scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/computed tomography (CT).
Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.
Read the detailed description
If you agree to take part in this study, right after your already scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.
You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of your breast that has, or is suspected to have cancer. To take images using the PEMFlex Solo II, the breast is placed between two flat panels on the scanning machine and compressed (flattened). The position of the breast for this procedure is similar to getting a mammogram, but the PEMFlex Solo II uses about 50% less force to compress the breast(s). The compression will be repeated on the other breast if you are having scans of both breasts performed.
It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.
Length of Study:
After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.
This is an investigational study. The PEMFlex Solo II is commercially available for PET scan imaging of the breast.
Up to 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Keywords
- PEM Uptake Value, PUV, Standardized Uptake Value, SUV, Malignancies of the Breast, [18F]-FDG-PET/CT scanning, Tumor, positron emission tomography/computed tomography, PET/CT scan
- Medical subject headings
- Breast Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between PUV and SUV of breast malignancies in patients undergoing [18F]-FDG-PET/CT scanning
Formal quantitative assessment of the correlation between PUVmax values and maximum standardized uptake value (SUVmax) values performed by testing whether the Pearson correlation between these values exceeds 0.7.
Measured: 20 minutes for imaging using PEMFlex Solo II
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Rohren, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031238
- Sponsor's protocol ID
- 2009-0479
- Status last verified
- Nov 2015
- First submitted
- 10 Dec 2009
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Compare the PEM Uptake Value (PUV) and Standardized Uptake Value (SUV) in Patients With Malignancies of the Breast
- ClinicalTrials.gov ID
- NCT01031238
- Acronym / sponsor ID
- 2009-0479
- Conditions
- Breast Cancer
- Keywords
- PEM Uptake Value, PUV, Standardized Uptake Value, SUV, Malignancies of the Breast, [18F]-FDG-PET/CT scanning, Tumor, positron emission tomography/computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for positron emission tomography (PET) scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/computed tomography (CT).
Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.
Detailed description
If you agree to take part in this study, right after your already scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.
You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of your breast that has, or is suspected to have cancer. To take images using the PEMFlex Solo II, the breast is placed between two flat panels on the scanning machine and compressed (flattened). The position of the breast for this procedure is similar to getting a mammogram, but the PEMFlex Solo II uses about 50% less force to compress the breast(s). The compression will be repeated on the other breast if you are having scans of both breasts performed.
It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.
Length of Study:
After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.
This is an investigational study. The PEMFlex Solo II is commercially available for PET scan imaging of the breast.
Up to 24 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected tumors of the breast, 18 years or older scheduled for routine clinical imaging at the PET/CT facility.
Key inclusion criteria (4 listed)
- A signed informed consent.
- Known or suspected malignancy involving the breast as determined by biopsy, physical examination or noninvasive imaging studies including plain films, CT, MR, ultrasound or nuclear medicine imaging.
- Scheduled for routine clinical imaging at the ACB PET/CT facility.
- Participant must be at least 18 years of age.
Key exclusion criteria (3 listed)
- Uncontrolled blood glucose levels (>200 mg/dl).
- Patient is unable to comprehend the requirements of the study.
- Patient is unable to undergo scanning of the known or suspected lesion with the high-resolution PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between PUV and SUV of breast malignancies in patients undergoing [18F]-FDG-PET/CT scanning
Time frame: 20 minutes for imaging using PEMFlex Solo II
Formal quantitative assessment of the correlation between PUVmax values and maximum standardized uptake value (SUVmax) values performed by testing whether the Pearson correlation between these values exceeds 0.7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Eric Rohren, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center 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 4 inclusion and 3 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 20 Nov 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between PUV and SUV of breast malignancies in patients undergoing [18F]-FDG-PET/CT scanning (time frame: 20 minutes for imaging using PEMFlex Solo II). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2015.