Breast NeoplasmPEM-FESNCT03266562
Estrogen Receptor Expression in Breast Cancer - Assessed With Positron Emission Mammography
A study testing F-18 FES and F-18 FDG in people with Breast Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
The primary objective of this study is to determine the correlation between the distribution of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of the breast, and the distribution of cells stained ER+ within the tumor by immunohistochemistry (IHC) measurements at surgical… Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- F-18 FES and F-18 FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 30 Apr 2019
- Phase
- Interventional
- 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 40 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will be offered enrollment if the time interval between initial diagnosis and surgery allows for performance of the PEM studies with both F18 FDG and F-18 FES, and they meet the following criteria:
- Postmenopausal women, as defined by
- Lack of menstrual periods for ≥ 12 months
- For women with prior hysterectomy and age < 60, a serum FSH level within the postmenopausal range
- Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP guidelines (staining in ≥ 1% of cells by immunohistochemistry)
- Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced breast MRI examination
- Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound, or MRI.
- Planned surgical excision of the breast cancer at Mayo Clinic, Rochester
Who cannot join
- Patients are excluded if they meet any of the following criteria:
- Premenopausal
- Unable to undergo PEM scanning (weight limit of 300 lbs. on PEM system or inability to lie prone for 30 minutes)
- Total serum bilirubin > 1.5 x upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion),
- Serum creatinine > 1.5 x upper limit of normal
- Patients who have received, are currently receiving, or planning to receive neoadjuvant systemic therapy prior to surgical excision
- Patients who will undergo core needle biopsy of the breast or axilla between the breast MRI and investigational PEM studies. NOTE: Axillary ultrasound with or without fine needle aspiration of an axillary mass or lymph node is allowed.
- Patients with breast implants?
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Heterogeneity of Estrogen Receptor Expression in Patients With Estrogen Receptor Positive Breast Cancer Using F-18 Fluoroestradiol and High Resolution Positron Emission Mammography
The primary objective of this study is to determine the correlation between the distribution of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of the breast, and the distribution of cells stained ER+ within the tumor by immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.
Read the detailed description
This pilot study will recruit up to 20 patients with newly diagnosed ER+ breast cancer who have recently undergone or are scheduled to undergo a clinically-indicated breast MRI examination and are scheduled for surgical excision of the breast cancer. All patients will undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. As F-18 FES is not an FDA-approved radiopharmaceutical, this FES study will be performed under an investigator IND cross-referenced to the National Cancer Institute IND 79,005 for F-18 FES. A time interval of 6-8 hours will be required between performance of the F-18 FDG study and the F-18 FES study. All patients will have the 2 PEM studies within 30 business days of the clinically indicated MRI. See Study Schema shown below. Subjects must meet the following eligibility criteria:
- Postmenopausal women, as defined by a. Lack of menstrual periods for ≥ 12 months b. For women with prior hysterectomy and age < 60, a serum FSH level within the postmenopausal range
- Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP guidelines (staining in ≥ 1% of cells by immunohistochemistry)
- Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced breast MRI examination
- Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound, or MRI.
- Planned surgical excision of the breast cancer at Mayo Clinic, Rochester
Study participants will be consented prior to undergoing the PEM studies. The order in which the PEM and MRI studies are performed will NOT be randomized, and will be dictated by patient schedule. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER expression in the tumor will be determined by immunohistochemistry on the pathologic tissue and findings will then be correlated with the ratio of activity in the co-registered images of F-18 FES and F-18 FDG. An integrated interpretation of the MRI and PEM images will be performed to match lesions seen on the three scans and will be made available to the ordering physician and surgeon.
- Conditions
- Breast Neoplasm
- Being tested
- F-18 FES, F-18 FDG
- Keywords
- Positron Emission Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 FESDiagnostic test
Evaluate uptake of F-18 FES in breast tissue
F-18 FDGDiagnostic test
Evaluate uptake of F-18 FDG in breast tissue
| Study group | Role | What they receive |
|---|---|---|
| FES vs FDG | Other | All patients will undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER expression in the tumor will be determined by immunohistochemistry on the pathologic tissue Receives: Diagnostic Test: F-18 FES; Diagnostic Test: F-18 FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of FES and estrogen receptors
The primary objective of this study is to determine the correlation between F-18 FES uptake on PEM, and distribution of ER+ tissue on pathology
Measured: 1 year
Secondary outcomes (1)
correlation of FES and FDG in breast tumors
The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start1 Sep 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Why it stopped: unable to recruit patients due to competing studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael O'Connor, Mayo Clinic
- Investigators
- Michael K O'Connor, Ph.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266562
- Sponsor's protocol ID
- 16-007764
- Acronym
- PEM-FES
- Status last verified
- May 2019
- First submitted
- 30 Nov 2016
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Heterogeneity of Estrogen Receptor Expression in Patients With Estrogen Receptor Positive Breast Cancer Using F-18 Fluoroestradiol and High Resolution Positron Emission Mammography
- ClinicalTrials.gov ID
- NCT03266562
- Acronym / sponsor ID
- PEM-FES / 16-007764
- Conditions
- Breast Neoplasm
- Keywords
- Positron Emission Mammography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit patients due to competing studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 30 Aug 2017 (actual)
- 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 primary objective of this study is to determine the correlation between the distribution of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of the breast, and the distribution of cells stained ER+ within the tumor by immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.
Detailed description
This pilot study will recruit up to 20 patients with newly diagnosed ER+ breast cancer who have recently undergone or are scheduled to undergo a clinically-indicated breast MRI examination and are scheduled for surgical excision of the breast cancer. All patients will undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. As F-18 FES is not an FDA-approved radiopharmaceutical, this FES study will be performed under an investigator IND cross-referenced to the National Cancer Institute IND 79,005 for F-18 FES. A time interval of 6-8 hours will be required between performance of the F-18 FDG study and the F-18 FES study. All patients will have the 2 PEM studies within 30 business days of the clinically indicated MRI. See Study Schema shown below. Subjects must meet the following eligibility criteria:
- Postmenopausal women, as defined by a. Lack of menstrual periods for ≥ 12 months b. For women with prior hysterectomy and age < 60, a serum FSH level within the postmenopausal range
- Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP guidelines (staining in ≥ 1% of cells by immunohistochemistry)
- Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced breast MRI examination
- Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound, or MRI.
- Planned surgical excision of the breast cancer at Mayo Clinic, Rochester
Study participants will be consented prior to undergoing the PEM studies. The order in which the PEM and MRI studies are performed will NOT be randomized, and will be dictated by patient schedule. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER expression in the tumor will be determined by immunohistochemistry on the pathologic tissue and findings will then be correlated with the ratio of activity in the co-registered images of F-18 FES and F-18 FDG. An integrated interpretation of the MRI and PEM images will be performed to match lesions seen on the three scans and will be made available to the ordering physician and surgeon.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES vs FDG | Other | Diagnostic Test: F-18 FES, Diagnostic Test: F-18 FDGAll patients will undergo two PEM studies, one with F-18 FDG and the second with F-18 FES. Co-registration of the PEM images from F-18 FDG and F-18 FES will be used to assess the heterogeneity of uptake of the F-18 FES relative to that of F-18 FDG. Heterogeneity of ER expression in the tumor will be determined by immunohistochemistry on the pathologic tissue |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eligible patients will be offered enrollment if the time interval between initial diagnosis and surgery allows for performance of the PEM studies with both F18 FDG and F-18 FES, and they meet the following criteria:
- Postmenopausal women, as defined by
- Histologic proof of invasive breast carcinoma that is ER positive per ASCO/CAP guidelines (staining in ≥ 1% of cells by immunohistochemistry)
- Extent of disease confirmed, or to be confirmed, on a clinical contrast-enhanced breast MRI examination
- Minimum size criteria for index cancer of 10 mm as measured on mammogram, ultrasound, or MRI.
Key exclusion criteria (8 listed)
- Premenopausal
- Unable to undergo PEM scanning (weight limit of 300 lbs. on PEM system or inability to lie prone for 30 minutes)
- Total serum bilirubin > 1.5 x upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion),
- Serum creatinine > 1.5 x upper limit of normal
- Patients who have received, are currently receiving, or planning to receive neoadjuvant systemic therapy prior to surgical excision
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 |
|---|---|---|
| F-18 FESEvaluate uptake of F-18 FES in breast tissue | Diagnostic test | FES vs FDG |
| F-18 FDGEvaluate uptake of F-18 FDG in breast tissue | Diagnostic test | FES vs FDG |
Primary outcome
correlation of FES and estrogen receptors
Time frame: 1 year
The primary objective of this study is to determine the correlation between F-18 FES uptake on PEM, and distribution of ER+ tissue on pathology
1 secondary outcome
correlation of FES and FDG in breast tumors
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael K O'Connor, Ph.D principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F-18 FES and F-18 FDG in people with Breast Neoplasm, run by Mayo Clinic 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 9 May 2019. 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 was withdrawn before enrolling participants, so there are no results.
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 of FES and estrogen receptors (time frame: 1 year). 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 9 May 2019.