Clinical trial · Interventional
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
NCT00968409CI-TRIAL-00020120FFNPcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F18-FFNP | Drug | — | UNRESOLVED |
| Laboratory Testing | Other | — | UNRESOLVED |
| PET | Radiation | — | UNRESOLVED |
| Safety Testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FFNP-PET/CT Imaging
- description
- All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.
- interventionNames
- Radiation: PET
- Other: Laboratory Testing
- Other: Safety Testing
- Drug: F18-FFNP
Primary outcomes (1)
- measure
- Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status
- timeFrame
- 4 years
Secondary outcomes (3)
- measure
- To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDehdashti 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 22331216