Breast CancerNCT01222416
PET/CT Evaluation of Treatment Response in Breast Cancer
A study testing Radiopharmaceutical Administration [18F]-FDG and Radiopharmaceutical: [18F]-FLT in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiopharmaceutical Administration [18F]-FDG and Radiopharmaceutical: [18F]-FLT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Apr 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
- Subjects must have histologically proven breast cancer
- Subjects are being considered for preoperative chemotherapy
- Subjects must be ≥ 18 years old. Sensor Sub-Study Only
- Palpable subcutaneous or known disease with one surface <1cm below surface of skin.
- A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.
Who cannot join
- Children will be excluded from this study.
- Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential).
- Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study.
- Intraluminal lesions will be excluded from the sensor sub-study.
- Non biopsy proven malignancy will be excluded from this study.
- Palpable subcutaneous or known disease with one surface >1cm below surface of skin will be excluded from the sensor sub-study.
- Draining or exposed malignant tumor will be excluded from the sensor sub-study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer
The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Radiopharmaceutical Administration [18F]-FDG, Radiopharmaceutical: [18F]-FLT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiopharmaceutical Administration [18F]-FDGRadiation
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.
Radiopharmaceutical: [18F]-FLTRadiation
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
| Study group | Role | What they receive |
|---|---|---|
| fluorodeoxyglucose PET/CT (FDG-PET/CT) | Experimental | A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Receives: Radiation: Radiopharmaceutical Administration [18F]-FDG |
| fluorodeoxythymidine PET/CT (FLT-PET/CT) | Experimental | A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. Receives: Radiation: Radiopharmaceutical: [18F]-FLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)
The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the
Measured: up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)
Secondary outcomes (1)
Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Slow accrual
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- A. Bapsi Chakravarthy, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01222416
- Sponsor's protocol ID
- VICC BRE 09108
- Status last verified
- Jun 2017
- First submitted
- 29 Sep 2010
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography (PET)-Computed Tomography (CT) PET/CT Evaluation of Treatment Response in Breast Cancer
- ClinicalTrials.gov ID
- NCT01222416
- Acronym / sponsor ID
- VICC BRE 09108
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluorodeoxyglucose PET/CT (FDG-PET/CT) | Experimental | Radiation: Radiopharmaceutical Administration [18F]-FDGA PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. |
| fluorodeoxythymidine PET/CT (FLT-PET/CT) | Experimental | Radiation: Radiopharmaceutical: [18F]-FLTA PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must have histologically proven breast cancer
- Subjects are being considered for preoperative chemotherapy
- Subjects must be ≥ 18 years old. Sensor Sub-Study Only
- Palpable subcutaneous or known disease with one surface <1cm below surface of skin.
- A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.
Key exclusion criteria (7 listed)
- Children will be excluded from this study.
- Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential).
- Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study.
- Intraluminal lesions will be excluded from the sensor sub-study.
- Non biopsy proven malignancy will be excluded from this study.
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 |
|---|---|---|
| Radiopharmaceutical Administration [18F]-FDGAdult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection. | Radiation | fluorodeoxyglucose PET/CT (FDG-PET/CT) |
| Radiopharmaceutical: [18F]-FLTAdult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection. | Radiation | fluorodeoxythymidine PET/CT (FLT-PET/CT) |
Primary outcome
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)
Time frame: up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)
The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the
1 secondary outcome
Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.
Time frame: 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink 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.
A. Bapsi Chakravarthy, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiopharmaceutical Administration [18F]-FDG and Radiopharmaceutical: [18F]-FLT in people with Breast Cancer, run by Vanderbilt-Ingram 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Jul 2017. 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 2 Jul 2017). 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?
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) (time frame: up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)). 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 2 Jul 2017.