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Labeling of Receptor Ligands and Other Compounds With Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using FFNP


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Labeling of Receptor Ligands and Other Compounds With Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using FFNP


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Farrokh Dehdashti, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University in St. Louis

Authority:

United States: Food and Drug Administration

Study ID:

FFNP 06-1034

NCT ID:

NCT00968409

Start Date:

January 2007

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Hormone Receptor
  • Breast Neoplasms
  • Carcinoma

Name

Location

Washington University / Barnes-Jewish HospitalSaint Louis, Missouri  63110