Brain Metastases From Breast CancerNCT01985971
F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer
A study testing PET/CT Imaging in people with Brain Metastases From Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases From Breast Cancer
- What is being tested?
- PET/CT Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 19 Aug 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.
- Subjects with prior resection of brain metastases with progressions on brain MRI.
- Histologic confirmation of breast cancer.
- Age of study subject must be > 18 years.
- ECOG Performance Status ≤ 2.
- Ability to undergo brain MR and PET imaging
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- Study subjects must have normal organ and marrow function as defined below:
- WBC >2,000/mmᶟ, platelets >90,000/mmᶟ, total bilirubin <2.0 mg/dl, creatinine <2.0 mg/dl.
- The effects of EF5 on the developing human fetus are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month). Should a woman become pregnant pr suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test the day of the F18 -EF5 PET scan prior to the F18 -EF5 injection.
- Ability to understand, participate and provide a documented signed informed consent.
- Subjects who are allergic to gadolinium will have MRI scans without gadolinium contrast.
Who cannot join
- History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.
- Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.
- Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.
- Subjects who are unable to provide informed consent.
- Patients with prior whole brain radiotherapy.
- Patients with moderate to severe renal failure, defined as estimated GFR less than 30 ml/Lmin 1.73m²
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.
- Conditions
- Brain Metastases From Breast Cancer
- Being tested
- PET/CT Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT ImagingRadiation
| Study group | Role | What they receive |
|---|---|---|
| EF5 | Experimental | Not described Receives: Radiation: PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startMar 2011
- Primary completion19 Aug 2016
- Study completion19 Aug 2016
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 Brain Metastases From Breast CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lilie Lin, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985971
- Sponsor's protocol ID
- UPCC 15910
- Status last verified
- Jan 2020
- First submitted
- 11 Nov 2013
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F18 EF5 PET/CT Imaging in Patients With Brain Metastases From Breast Cancer
- ClinicalTrials.gov ID
- NCT01985971
- Acronym / sponsor ID
- UPCC 15910
- Conditions
- Brain Metastases From Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- 19 Aug 2016 (actual)
- Study completion
- 19 Aug 2016 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To estimate the presence of hypoxia in individual lesions after radiotherapy in patients with brain metastases from breast cancer as identified by F18 EF5 PET/CT imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EF5 | Experimental | Radiation: PET/CT Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects with measurable brain metastases of at least 1 cm in any plane based on anatomic imaging.
- Subjects with prior resection of brain metastases with progressions on brain MRI.
- Histologic confirmation of breast cancer.
- Age of study subject must be > 18 years.
- ECOG Performance Status ≤ 2.
Key exclusion criteria (6 listed)
- History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5.
- Pregnant women are excluded because EF5 has an unknown risk for adverse events in fetuses and nursing infants secondary the administration of EF5 to the mother. Breastfeeding should be discontinued if EF5 is administered to the mother.
- Subject has any other condition or personal circumstance that, in the judgement of the investigator, might interfere with the collection of complete good quality data.
- Subjects who are unable to provide informed consent.
- Patients with prior whole brain radiotherapy.
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 |
|---|---|---|
| PET/CT Imaging | Radiation | EF5 |
Primary outcome
Number of Participants With Adverse Events
Time frame: 2 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 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.
Lilie Lin, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT Imaging in people with Brain Metastases From Breast Cancer, run by Abramson Cancer Center at Penn Medicine 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 11 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 31 Jan 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 31 Jan 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?
Number of Participants With Adverse Events (time frame: 2 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 31 Jan 2020.