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Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Farrokh Dehdashti, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00968409
First received: August 28, 2009
Last updated: February 5, 2014
Last verified: February 2014

August 28, 2009
February 5, 2014
January 2007
January 2011   (final data collection date for primary outcome measure)
Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00968409 on ClinicalTrials.gov Archive Site
  • To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To determine the relationship between tumor FFNP uptake and in vitro status of progesterone receptor [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To calculate human dosimetry and overall safety of FFNP-PET imaging [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Radiation: PET
    PET imaging following injection of F18-FFNP to image hormone receptor status in patients with newly diagnosed breast cancer
  • Other: Laboratory Testing
    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
  • Other: Safety Testing
    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.
  • Drug: F18-FFNP
    injection of F18-FFNP
Not Provided
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-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-d ione. J Nucl Med. 2012 Mar;53(3):363-70. doi: 10.2967/jnumed.111.098319. Epub 2012 Feb 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2011
January 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00968409
FFNP 06-1034
Yes
Farrokh Dehdashti, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Farrokh Dehdashti, M.D. Washington University School of Medicine
Washington University School of Medicine
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP