Breast CancerEarly Phase 1NCT01916122
Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status
A Early Phase 1 study testing Fluorestradiol (FES) and PET/CT Imaging in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
These are tumors which expresses estrogen receptors. Estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. This study is being performed to imaging the amount of estrogen receptors expressed in the tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fluorestradiol (FES) and PET/CT Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2013to 3 Apr 2024
- Phase
- Early Phase 1
- 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
Who may be able to join
- Patients with histologic/immunochemical proof of ER+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry).
- Patients who are to be treated with clinically approved or experimental regimens where ER has an important role
- ECOG performance status of 0-2.
- Patients must provide written informed consent
Who cannot join
- Age <18 years
- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia)
- Pregnancy or lactation
- Total serum bilirubin > 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion). Increased serum bilirubin due to Gilbert's syndrome is permitted.
- Serum creatinine > 1.5 times upper limit of normal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
These are tumors which expresses estrogen receptors. Estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. This study is being performed to imaging the amount of estrogen receptors expressed in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a machine that can take pictures of where the FES is and how much FES is present. The results of this study may help researchers know whether FES can be used to monitor changes in estrogen receptors in tumors during treatment.
- Conditions
- Breast Cancer
- Being tested
- Fluorestradiol (FES), PET/CT Imaging
- Keywords
- Fluorestradiol (FES), PET/CT scan, Estrogen Receptor, 13-071
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorestradiol (FES)Drug
PET/CT ImagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| (FES) PET/CT for Imaging | Experimental | FES PET/CT studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 5 mCi (+/- 10%) of FES PET/CT will be injected intravenously. 60 (+/- 10) minutes following tracer injection, the patient will be positioned on a GE Discovery PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first, 60-80mAs, 120-140kVp, with a 5mm slice thickness while the patient was free breathing. PET will be acquired at 3-5 minutes per bed position using the 3D mode, approximately 6-7 bed positions. FES PET/CT imaging will take less than 60 minutes. Scans will be reconstructed with iterative reconstruction.
If follow-up FES PT/CT scans are performed on a patient, then the same parameters will be used as the initial FES PET/CT scan. Receives: Drug: Fluorestradiol (FES); Procedure: PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
FES PET/CT scanning
The objective of this study is only to allow FES PET/CT scanning of patients at MSKCC. This protocol is an "umbrella protocol" to allow FES PET/CT scanning to be used in other companion protocols.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start1 Aug 2013
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
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 Memorial Sloan Kettering 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randy Yeh, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916122
- Sponsor's protocol ID
- 13-071
- Status last verified
- Apr 2024
- First submitted
- 2 Aug 2013
- Last updated
- 5 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status
- ClinicalTrials.gov ID
- NCT01916122
- Acronym / sponsor ID
- 13-071
- Conditions
- Breast Cancer
- Keywords
- Fluorestradiol (FES), PET/CT scan, Estrogen Receptor, 13-071
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 5 Aug 2013 (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.
These are tumors which expresses estrogen receptors. Estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. This study is being performed to imaging the amount of estrogen receptors expressed in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a machine that can take pictures of where the FES is and how much FES is present. The results of this study may help researchers know whether FES can be used to monitor changes in estrogen receptors in tumors during treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (FES) PET/CT for Imaging | Experimental | Drug: Fluorestradiol (FES), Procedure: PET/CT ImagingFES PET/CT studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 5 mCi (+/- 10%) of FES PET/CT will be injected intravenously. 60 (+/- 10) minutes following tracer injection, the patient will be positioned on a GE Discovery PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first, 60-80mAs, 120-140kVp, with a 5mm slice thickness while the patient was free breathing. PET will be acquired at 3-5 minutes per bed position using the 3D mode, approximately 6-7 bed positions. FES PET/CT imaging will take less than 60 minutes. Scans will be reconstructed with iterative reconstruction. If follow-up FES PT/CT scans are performed on a patient, then the same parameters will be used as the initial FES PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histologic/immunochemical proof of ER+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry).
- Patients who are to be treated with clinically approved or experimental regimens where ER has an important role
- ECOG performance status of 0-2.
- Patients must provide written informed consent
Key exclusion criteria (5 listed)
- Age <18 years
- Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia)
- Pregnancy or lactation
- Total serum bilirubin > 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion). Increased serum bilirubin due to Gilbert's syndrome is permitted.
- Serum creatinine > 1.5 times upper limit of normal.
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 |
|---|---|---|
| Fluorestradiol (FES) | Drug | (FES) PET/CT for Imaging |
| PET/CT Imaging | Procedure or surgery | (FES) PET/CT for Imaging |
Primary outcome
FES PET/CT scanning
Time frame: 5 years
The objective of this study is only to allow FES PET/CT scanning of patients at MSKCC. This protocol is an "umbrella protocol" to allow FES PET/CT scanning to be used in other companion protocols.
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 5 Apr 2024.
- Memorial Sloan Kettering Cancer CenterLink 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.
Randy Yeh, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluorestradiol (FES) and PET/CT Imaging in people with Breast Cancer, run by Memorial Sloan Kettering 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 5 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 5 Apr 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
FES PET/CT scanning (time frame: 5 years). 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 5 Apr 2024.