None listed
Conditions
Brief summary
The primary purpose of this study is to determine whether Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) scan is more sensitive in detecting small metastatic disease in renal cell cancer than conventional computed tomography (CT) scans. Who is it for? You may be eligible to join this study if you have been diagnosed with renal cell carcinoma in the past 6 weeks. Study details: All participants will undergo a 68Ga-labelled PSMA PET scan in addition to the standard pf care staging CT scans offered. A standard imaging to diagnose renal cell carcinoma is using multi-phase contrast CT scan which participants would have had for the diagnosis. The imaging is then compared to PET scan, which involves receiving a radio-isotope via a drip. This scan is commonly used in prostate cancer staging. You will be required to have an injection, wait 90 minutes, then lie down on a table inside the PET machine for 30 minutes. Scans will be assessed for small metastatic disease and patient records will be assessed to determine if the use of PET scan has changed patient management. It is hoped that the findings of this pilot trial will help to establish whether PSMA PET may be more useful in identifying micrometastases than the CT staging scans alone which are currently being offered. In total, all participants of the trial would have had 1 multiphase CT scan to be eligible for referral, and 1 non-contrast single phase CT scan will be performed with 1 PET scan.
Interventions
[68Ga]Gallium-labelled Prostate-specific membrane antigen ligand (radio-isotope) will be injected into the blood stream via intravenous access (18-22 Gauge cannula). The dose is 150MBq(5 micrograms). The radio-isotope is used commonly for prostate cancer staging and its safety profile is well documented. The radiation dose is similar to other nuclear medicine studies such as bone scan which are commonly used. After 90 minutes, the participants will be placed in the positron emission tomograph
[68Ga]Gallium-labelled Prostate-specific membrane antigen ligand (radio-isotope) will be injected into the blood stream via intravenous access (18-22 Gauge cannula). The dose is 150MBq(5 micrograms). The radio-isotope is used commonly for prostate cancer staging and its safety profile is well documented. The radiation dose is similar to other nuclear medicine studies such as bone scan which are commonly used. After 90 minutes, the participants will be placed in the positron emission tomography (PET) scanner and the scan will begin (scanning takes ~30 minutes). A low dose single phase non-contrast wholebody computed tomography (CT) scan will be performed during the PET scan as this helps to interpret the PET scan. This scan will be undertaken once in the study. The images will be interpreted by a radiologist.
Sponsors
Dr Simon Wood
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with renal mass larger than 2cm 2. Indeterminant or likely metastatic lesions on staging CT scan 3. No known problems with peripheral intravenous or central line access 4. Able to undergo study imaging within 6 weeks of diagnosis 5. Able to provide informed signed consent
Exclusion criteria
1. Age under 18 years 2. Administered radioisotope within 5 physical half-lives prior to PSMA PET 3. Unable to lie flat during or unable to tolerate PET 4. Prior history of any other malignancy within last 2 years 5. Contraindication to PET scan or 68 Ga PSMA PET ligand 6. Claustrophobia not manageable by oral sedatives. i.e. Temazepam. 7. Renal impairment or haemodialysis.
Outcome results
None listed