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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET | Radiation | PET imaging following injection of F18-FFNP to image hormone receptor status in patients with newly diagnosed breast cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose | 4 years | |
| To determine the relationship between tumor FFNP uptake and in vitro status of progesterone receptor | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farrokh Dehdashti, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University / Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22331216 | Result | 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. |
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| Laboratory Testing | Other | 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 Testing | Other | 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-FFNP | Drug | injection of F18-FFNP |
|
| To calculate human dosimetry and overall safety of FFNP-PET imaging | 4 years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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