Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)NCT01018251
Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer
A study testing 3'-deoxy-3'-[18F]fluorothymidine, Positron Emission Tomography/computed tomography and FLT-PET/CT in people with Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment), run by Abramson Cancer Center at Penn Medicine.
Trial summary
This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)
- What is being tested?
- 3'-deoxy-3'-[18F]fluorothymidine, Positron Emission Tomography/computed tomography and FLT-PET/CT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jun 2011
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)
- Participants must be planning to have surgery at the Hospital of the University of Pennsylvania
- Participants must be able to tolerating lying on the table for about an hour
- Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)
Who cannot join
- Pregnant women
- History of severe renal disease
- Prior history of breast cancer of the study breast within the last five years.
About this study
Official title: Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT
This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,
Read the detailed description
Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.
- Being tested
- 3'-deoxy-3'-[18F]fluorothymidine, Positron Emission Tomography/computed tomography, FLT-PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3'-deoxy-3'-[18F]fluorothymidineOther
Also called 18F-FLT
Given IV
Positron Emission Tomography/computed tomographyProcedure or surgery
FLT-PET/CTRadiation
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergoing definitive surgery after cancer diagnosis undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT)-PET prior to definitive surgery. Patients undergoing neoadjuvant chemotherapy prior to definitive surgery undergo FLT-PET prior to and after completion of neoadjuvant chemotherapy Receives: Other: 3'-deoxy-3'-[18F]fluorothymidine; Procedure: Positron Emission Tomography/computed tomography; Radiation: FLT-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of FLT-PET comparing with standard FDG-PET
Correlate SUV with % Ki67 nuclear stain
Secondary outcomes (2)
Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used)
Tumor volume pre and post chemotherapy as assessed by clinical exam, breast imaging studies, histopathological examination, and breast cancer outcome parameters (when neoadjuvant therapy is used)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018251
- Sponsor's protocol ID
- UPCC 01109
- Status last verified
- Dec 2015
- First submitted
- 18 Nov 2009
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT
- ClinicalTrials.gov ID
- NCT01018251
- Acronym / sponsor ID
- UPCC 01109
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Nov 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.
This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,
Detailed description
Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Other: 3'-deoxy-3'-[18F]fluorothymidine, Procedure: Positron Emission Tomography/computed tomography, Radiation: FLT-PET/CTPatients undergoing definitive surgery after cancer diagnosis undergo 3'-deoxy-3'-[18F] fluorothymidine (FLT)-PET prior to definitive surgery. Patients undergoing neoadjuvant chemotherapy prior to definitive surgery undergo FLT-PET prior to and after completion of neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)
- Participants must be planning to have surgery at the Hospital of the University of Pennsylvania
- Participants must be able to tolerating lying on the table for about an hour
- Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)
Key exclusion criteria (3 listed)
- Pregnant women
- History of severe renal disease
- Prior history of breast cancer of the study breast within the last five years.
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 |
|---|---|---|
| 3'-deoxy-3'-[18F]fluorothymidineAlso: 18F-FLTGiven IV | Other | Arm I |
| Positron Emission Tomography/computed tomography | Procedure or surgery | Arm I |
| FLT-PET/CT | Radiation | Arm I |
Primary outcome
Sensitivity and specificity of FLT-PET comparing with standard FDG-PET
Correlate SUV with % Ki67 nuclear stain
2 secondary outcomes
Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used)
Tumor volume pre and post chemotherapy as assessed by clinical exam, breast imaging studies, histopathological examination, and breast cancer outcome parameters (when neoadjuvant therapy is used)
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 15 Dec 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 3'-deoxy-3'-[18F]fluorothymidine, Positron Emission Tomography/computed tomography and FLT-PET/CT in people with Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment), run by Abramson Cancer Center at Penn Medicine.
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: withdrawn, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity and specificity of FLT-PET comparing with standard FDG-PET. The study lists 2 primary outcomes in all. 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 15 Dec 2015.