Breast CancerPhase 1NCT02204462
FBnTP Imaging of Breast Cancer
A Phase 1 study testing FBnTP in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Our preclinical studies suggest the capacity of the positron emission tomography imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools. Read more about this study
- Who is it for?
- Ages 26 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FBnTP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2015to 13 Dec 2021
- Phase
- 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 26 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer)
- Age > 25 Ability and willingness to sign informed consent prior to any study procedure.
- Positive indication of disease on mammogram or MRI scan.
- Candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon.
- Ability to undergo up to 90 minutes of PEM imaging.
Who cannot join
- Any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures.
- Past or present history of active substance abuse (drug or alcohol).
- Inability to tolerate venous access.
- Pregnant females are excluded from this study. All females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to FBnTP administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer
Our preclinical studies suggest the capacity of the positron emission tomography imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools.
Read the detailed description
Breast cancer is the most widespread type of cancer among women in the USA, and the second leading cause of death. The National Cancer Institute estimates that in 2013, in the USA, 226,870 women will be diagnosed with breast cancer and 39,510 women will die of breast cancer, most of them of progressive metastatic disease. Early detection and treatment of the disease, when the tumor is still localized and at a high curability state, is the outmost important determinant of disease-free survival of breast cancer patients. Survival rate of women first diagnosed with pure early-stage noninvasive tumor (ductal carcinoma in situ- DCIS) is nearly 98%, which drops to 48% in patients with advanced disease.Yet, early detection of breast cancer is relatively poor. This is best exemplify by the astonishing percentage of benign biopsies; 80% of 1.7 million biopsies in the USA, at a cost of $3 billion; whereas, only small fraction (~20%) of newly diagnosed women are found to have pure DCIS.
Our preclinical studies suggest the capacity of the positron emission tomography (PET) imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools. Accordingly, the present protocol is designed to extend the preclinical findings into clinical studies in breast cancer women, and to assess the effectiveness of 18F-FBnTP in detecting breast malignant lesions, in comparison with magnetic resonance imaging and fluorodeoxyglucose PET imaging.
- Conditions
- Breast Cancer
- Being tested
- FBnTP
- Keywords
- PET, Positron Emission Tomography, Breast Cancer, Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FBnTPDrug
Also called Fluorobenzyl triphenyl phosphonium
A PET imaging radiotracer
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed breast cancer | Experimental | Patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e. index cancer). Patients will undergo FBnTP PET imaging for detection of malignant breast cancer. Receives: Drug: FBnTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malignant breast cancer detection
A feasibility study to assess the capacity of 18F-FBnTP PEM to detect and localize malignant breast lesions. Histopathology results will serve as reference standard.
Measured: Pre-treatment
Secondary outcomes (1)
Imaging comparison
To evaluate the concordance in detecting malignant breast lesions between FBnTP PEM and available diagnostic tests such as mammogram, 18F-FDG PEM or MRI.
Measured: Pre-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study start12 Mar 2015
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Why it stopped: Lock of funding
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 Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Pomper, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204462
- Sponsor's protocol ID
- J13162
- Other IDs
- NA_00084913
- Status last verified
- Dec 2021
- First submitted
- 28 Jul 2014
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: via manuscripts publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FBnTP Positron Emission Mammography Imaging of Mitochondria Function - Breast Cancer
- ClinicalTrials.gov ID
- NCT02204462
- Acronym / sponsor ID
- J13162
- Conditions
- Breast Cancer
- Keywords
- PET, Positron Emission Tomography, Breast Cancer, Imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lock of funding
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 12 Mar 2015 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 30 Jul 2014 (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.
Our preclinical studies suggest the capacity of the positron emission tomography imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools.
Detailed description
Breast cancer is the most widespread type of cancer among women in the USA, and the second leading cause of death. The National Cancer Institute estimates that in 2013, in the USA, 226,870 women will be diagnosed with breast cancer and 39,510 women will die of breast cancer, most of them of progressive metastatic disease. Early detection and treatment of the disease, when the tumor is still localized and at a high curability state, is the outmost important determinant of disease-free survival of breast cancer patients. Survival rate of women first diagnosed with pure early-stage noninvasive tumor (ductal carcinoma in situ- DCIS) is nearly 98%, which drops to 48% in patients with advanced disease.Yet, early detection of breast cancer is relatively poor. This is best exemplify by the astonishing percentage of benign biopsies; 80% of 1.7 million biopsies in the USA, at a cost of $3 billion; whereas, only small fraction (~20%) of newly diagnosed women are found to have pure DCIS.
Our preclinical studies suggest the capacity of the positron emission tomography (PET) imaging agent 18F-fluorobenzyl triphenyl phosphonium (FBnTP) to detects early-stage small breast tumors (e.g., DCIS), and differentiates benign from malignant masses with better accuracy than that obtained by existing breast imaging tools. Accordingly, the present protocol is designed to extend the preclinical findings into clinical studies in breast cancer women, and to assess the effectiveness of 18F-FBnTP in detecting breast malignant lesions, in comparison with magnetic resonance imaging and fluorodeoxyglucose PET imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed breast cancer | Experimental | Drug: FBnTPPatients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e. index cancer). Patients will undergo FBnTP PET imaging for detection of malignant breast cancer. |
Who may qualify
- Ages
- 26 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients with newly-diagnosed invasive and/or intraductal breast cancer detected by core needle or vacuum-assisted biopsy (i.e., index cancer)
- Age > 25 Ability and willingness to sign informed consent prior to any study procedure.
- Positive indication of disease on mammogram or MRI scan.
- Candidate for breast cancer surgery on the basis of recommendation of a breast cancer surgeon.
- Ability to undergo up to 90 minutes of PEM imaging.
Key exclusion criteria (4 listed)
- Any active or chronic illness that, in the opinion of the investigators, would make the study unsafe or limit compliance with study procedures.
- Past or present history of active substance abuse (drug or alcohol).
- Inability to tolerate venous access.
- Pregnant females are excluded from this study. All females of child-bearing potential will undergo a serum pregnancy test within 48 hours prior to FBnTP administration.
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 |
|---|---|---|
| FBnTPAlso: Fluorobenzyl triphenyl phosphoniumA PET imaging radiotracer | Drug | Newly diagnosed breast cancer |
Primary outcome
Malignant breast cancer detection
Time frame: Pre-treatment
A feasibility study to assess the capacity of 18F-FBnTP PEM to detect and localize malignant breast lesions. Histopathology results will serve as reference standard.
1 secondary outcome
Imaging comparison
Time frame: Pre-treatment
Results and safety
The study was stopped early (reason given: Lock of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: Yes. via manuscripts publication
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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.
Martin Pomper, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FBnTP in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 4 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 15 Dec 2021. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Lock of funding). Results are not available in the source record.
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?
Malignant breast cancer detection (time frame: Pre-treatment). 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 2021.