Labeling of Receptor Ligands and Other Compounds With Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using FFNP
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
FFNP-PET/CT Imaging
All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.
干预措施: PET (Radiation)
FFNP-PET/CT Imaging
All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.
干预措施: Laboratory Testing (Other)
FFNP-PET/CT Imaging
All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.
干预措施: Safety Testing (Other)
FFNP-PET/CT Imaging
All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.
干预措施: F18-FFNP (Drug)
结局指标
主要结局
Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status
时间窗: 4 years
次要结局
- To calculate human dosimetry and overall safety of FFNP-PET imaging(4 years)
- 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)
研究者
Farrokh Dehdashti
Principal Investigator
Washington University School of Medicine