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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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: PET
Other: Laboratory Testing
Other: Safety Testing
Drug: F18-FFNP
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: January 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968409

Locations
United States, Missouri
Washington University / Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Farrokh Dehdashti, M.D. Washington University School of Medicine
  More Information

Publications:
Responsible Party: Farrokh Dehdashti, Principal Investigator, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00968409     History of Changes
Other Study ID Numbers: FFNP 06-1034
Study First Received: August 28, 2009
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Breast Cancer
Hormone Receptor

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on November 24, 2014