Metastatic renal cell carcinoma.
Conditions
Interventions
Product Name: 18-fluoride labelled sodium fluoride/[18F]NaF INJECTION
Pharmaceutical Form: Injection
Sponsors
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the site and extent of bone metastases detected with 18F-NaF PET-CT, multidetector CT and bone scintigraphy for detecting bone metastases in renal cell carcinoma. To assess whether 18F-sodium fluoride PET and CT images can be used to predict or correlate response to treatment in metastatic renal cell carcinoma. To assess arterial calcium on the CT and to assess whether this correlates with the 18F-NaF uptake.;Primary end point(s): To assess the number of metastases detected with 18F-NaF PET-CT, bone scintigraphy and multidetector CT alone.;Main Objective: To determine if 18F-labelled sodium fluoride (18F-NaF) PET-CT is more sensitive at detecting bone metastases in renal cell carcinoma than conventional techniques i.e. planar bone scintigraphy and computed tomography (CT). | — |
Countries
United Kingdom
Outcome results
None listed