18F-labelled sodium fluoride positron emission tomography - computed tomography (PET-CT) for renal cell carcinoma (RCC)

Not Applicable

Completed

• Conditions: Renal cell carcinoma; Cancer

• Registration Number: ISRCTN66828876
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge (UK) - Joint Sponsorship

Brief Summary

2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26202597 (added 16/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-28
• Study Completion: 2012-01-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male or female, 18 years of age or older with no upper age limit
2. Must be able to provide a written informed consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (ICH/GCP), national and local regulations
3. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment
4. Treatment-naïve patients in the first instance. If at 6 months, insufficient numbers (less than 5) can be recruited in the time period between diagnosis and treatment, then patients that have been treated will also be recruited after the first cycle of chemotherapy.
5. Life expectancy of 12 weeks or greater
6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria

1. 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
2. Allergy to methylene diphosphonate used in bone scintigraphy
3. Any metabolic disorder that involves the skeletal system
4. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
5. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrolment.
6. 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
7. Not suitable to undergo a PET study, e.g., extreme obesity: greater than 226 kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified