A Pilot Study Investigating the Sensitivity of 18F-labelled Sodium Fluoride PET-CT for Detecting Skeletal Metastases in Renal Cell Carcinoma compared to Planar Bone Scintigraphy and Multidetector CT - 18F-Fluoride PET-CT for Detecting Bone Metastases in RCC

Phase 1

Conditions: Metastatic renal cell carcinoma.

Registration Number: EUCTR2010-024624-20-GB

Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Metastatic (Stage IV) renal cell carcinoma of the kidney with known or suspected bone metastasis. Known metastases may have been identified using any imaging modality (e.g. plain film, bone scintigraphy, CT, MRI). For the purposes of this study, bone metastases may be suspected if there is bone pain, a bone mass or neurological symptoms felt to be due to bone metastases. Male or female, 18 years of age or older. Life expectancy of 12 weeks or greater. ECOG performance status 0, 1 or 2. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Before patient registration, written informed consent, must be given according to ICH/GCP, national and local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Diagnosis of any other malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer. Allergy to methylene diphosphonate used in bone scintigraphy. Any metabolic disorder that involves the skeletal system. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to imaging. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or in the judgment of the investigator would make it undesirable for the patient to enter the trial.