E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic renal cell carcinoma. |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
|
E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To assess the number of metastases detected with 18F-NaF PET-CT, bone scintigraphy and multidetector CT alone. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description |
This is an imaging IMP. There will be no direct therapeutic benefit to the patient. |
|
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial is defined as the date when all patients recruited have completed their imaging assessments and have had one year of follow up |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |