Breast CancerPhase 1FFNPNCT00968409
Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)
A Phase 1 study testing PET, Laboratory Testing and Safety Testing in people with Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive form of the hormone progesterone called FFNP will give the same results as hormone receptor testing already performed on tissue used to diagnose 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?
- PET, Laboratory Testing and Safety Testing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jan 2011
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 18 years of age or older
- Biopsy-proven breast cancer
- Tumor estrogen-receptor and progesterone-receptor status already determined or scheduled to be determined at time of surgery without intervening therapy.
- Primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
- Able to give informed consent
- Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and / or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of FFNP) is negative.
Who cannot join
- No previous history of hormone therapy; NOTE - subjects who were treated with hormone therapy for reasons other than breast cancer or breast cancer prevention may be allowed to participate after review of history by the primary investigator
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
- Unable to tolerate 60-90 minutes of PET imaging per imaging session
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University / Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Labeling of Receptor Ligands and Other Compounds With Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using FFNP
The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive form of the hormone progesterone called FFNP will give the same results as hormone receptor testing already performed on tissue used to diagnose breast cancer.
- Conditions
- Breast Cancer
- Being tested
- PET, Laboratory Testing, Safety Testing, F18-FFNP
- Keywords
- Breast Cancer, Hormone Receptor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETRadiation
PET imaging following injection of F18-FFNP to image hormone receptor status in patients with newly diagnosed breast cancer
Laboratory TestingOther
Blood and urine samples for standard laboratory testing and radioactive counts will be obtained during the imaging sessions. Testing will include: urinalysis, complete blood count, comprehensive metabolic panel, and progesterone levels
Safety TestingOther
ECG tracings and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during and after the imaging sessions.
F18-FFNPDrug
injection of F18-FFNP
| Study group | Role | What they receive |
|---|---|---|
| FFNP-PET/CT Imaging | Other | All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing. Receives: Radiation: PET; Other: Laboratory Testing; Other: Safety Testing; Drug: F18-FFNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status
Measured: 4 years
Secondary outcomes (3)
To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose
Measured: 4 years
To determine the relationship between tumor FFNP uptake and in vitro status of progesterone receptor
Measured: 4 years
To calculate human dosimetry and overall safety of FFNP-PET imaging
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJan 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farrokh Dehdashti, Washington University School of Medicine
- Investigators
- Farrokh Dehdashti, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968409
- Sponsor's protocol ID
- FFNP 06-1034
- Acronym
- FFNP
- Status last verified
- Dec 2015
- First submitted
- 28 Aug 2009
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dehdashti F, Laforest R, Gao F, Aft RL, Dence CS, Zhou D, Shoghi KI, Siegel BA, Katzenellenbogen JA, Welch MJ. Assessment of progesterone receptors in breast carcinoma by PET with 21-18F-fluoro-16alpha,17alpha-[(R)-(1'-alpha-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione. J Nucl Med. 2012 Mar;53(3):363-70. doi: 10.2967/jnumed.111.098319. Epub 2012 Feb 13.
PubMed 22331216
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labeling of Receptor Ligands and Other Compounds With Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using FFNP
- ClinicalTrials.gov ID
- NCT00968409
- Acronym / sponsor ID
- FFNP / FFNP 06-1034
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Hormone Receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 31 Aug 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.
The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive form of the hormone progesterone called FFNP will give the same results as hormone receptor testing already performed on tissue used to diagnose breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFNP-PET/CT Imaging | Other | Radiation: PET, Other: Laboratory Testing, Other: Safety Testing, Drug: F18-FFNPAll subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients 18 years of age or older
- Biopsy-proven breast cancer
- Tumor estrogen-receptor and progesterone-receptor status already determined or scheduled to be determined at time of surgery without intervening therapy.
- Primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
- Able to give informed consent
Key exclusion criteria (3 listed)
- No previous history of hormone therapy; NOTE - subjects who were treated with hormone therapy for reasons other than breast cancer or breast cancer prevention may be allowed to participate after review of history by the primary investigator
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
- Unable to tolerate 60-90 minutes of PET imaging per imaging session
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 |
|---|---|---|
| PETPET imaging following injection of F18-FFNP to image hormone receptor status in patients with newly diagnosed breast cancer | Radiation | FFNP-PET/CT Imaging |
| Laboratory TestingBlood and urine samples for standard laboratory testing and radioactive counts will be obtained during the imaging sessions. Testing will include: urinalysis, complete blood count, comprehensive metabolic panel, and progesterone levels | Other | FFNP-PET/CT Imaging |
| Safety TestingECG tracings and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during and after the imaging sessions. | Other | FFNP-PET/CT Imaging |
| F18-FFNPinjection of F18-FFNP | Drug | FFNP-PET/CT Imaging |
Primary outcome
Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status
Time frame: 4 years
3 secondary outcomes
To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose
Time frame: 4 years
To determine the relationship between tumor FFNP uptake and in vitro status of progesterone receptor
Time frame: 4 years
To calculate human dosimetry and overall safety of FFNP-PET imaging
Time frame: 4 years
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 9 Dec 2015.
- Results publication: PubMed 22331216Dehdashti F, Laforest R, Gao F, Aft RL, Dence CS, Zhou D, Shoghi KI, Siegel BA, Katzenellenbogen JA, Welch MJ. Assessment of progesterone receptors in breast carcinoma by PET with 21-18F-fluoro-16alpha,17alpha-[(R)-(1'-alpha-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione. J Nucl Med. 2012 Mar;53(3):363-70. doi: 10.2967/jnumed.111.098319. Epub 2012 Feb 13.
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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.
Farrokh Dehdashti, M.D. principal investigator
Washington University School of Medicine
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 PET, Laboratory Testing and Safety Testing in people with Breast Cancer, run by Washington University School of 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 6 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: finished, as of the sponsor's last update on 9 Dec 2015. 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 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?
Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968409, which also lists 1 linked publication.
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 9 Dec 2015.