NCT00968409

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jan 2007

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 9, 2015

Status Verified

December 1, 2015

Enrollment Period

4 years

First QC Date

August 28, 2009

Last Update Submit

December 7, 2015

Conditions

Breast Cancer

Keywords

Breast CancerHormone Receptor

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status

    4 years

Secondary Outcomes (3)

  • 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

  • To calculate human dosimetry and overall safety of FFNP-PET imaging

    4 years

Study Arms (1)

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.

Radiation: PETOther: Laboratory TestingOther: Safety TestingDrug: F18-FFNP

Interventions

PETRADIATION

PET imaging following injection of F18-FFNP to image hormone receptor status in patients with newly diagnosed breast cancer

FFNP-PET/CT Imaging
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

FFNP-PET/CT Imaging
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.

FFNP-PET/CT Imaging
F18-FFNPDRUG

injection of F18-FFNP

FFNP-PET/CT Imaging

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University / Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 22331216RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Farrokh Dehdashti, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 9, 2015

Record last verified: 2015-12

Locations

US(1)