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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PET

Laboratory Testing

Safety Testing

F18-FFNP

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, Hormone Receptor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Washington University / Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FFNP-PET/CT Imaging

Arm Description

All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose

To determine the relationship between tumor FFNP uptake and in vitro status of progesterone receptor

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

Full Information

NCT ID

NCT00968409

First Posted

August 28, 2009

Last Updated

December 7, 2015

Sponsor

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00968409

Brief Title

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

Acronym

FFNP

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer, Hormone Receptor

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FFNP-PET/CT Imaging

Arm Type

Other

Arm Description

All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.

Intervention Type

Radiation

Intervention Name(s)

PET

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Laboratory Testing

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Safety Testing

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

F18-FFNP

Intervention Description

injection of F18-FFNP

Primary Outcome Measure Information:

Title

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

Time Frame

4 years

Secondary Outcome Measure Information:

Title

To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose

Time Frame

4 years

Title

To determine the relationship between tumor FFNP uptake and in vitro status of progesterone receptor

Time Frame

4 years

Title

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

Time Frame

4 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Farrokh Dehdashti, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University / Barnes-Jewish Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22331216

Citation

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.

Results Reference

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

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