None listed
Conditions
Brief summary
The aim of this study is to compare the accuracy of novel, dynamic and static functional imaging, and also morphological imaging, with standard of care imaging for the detection of liver metastases in patients with neuroendocrine tumour (NET). Who is it for? You may be eligible to join this study if you aged 18 years or above and have been diagnosed with histologically proven WHO Grade I or Grade II NET with known liver metastases. Study details All participants in this study will receive three scans on a single day: an initial PET-MRI Scan, followed by a PET-CT Scan, and then a final PET-MRI Scan. For the initial PET-MRI scan a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called Ga-68-DOTATATE as well as a special dye called contrast. The scan involves lying flat with knees supported and arms resting by your side. You will be scanned from the top of your head to the middle of your thighs. The scan time for the PET-MRI will be approximately 45 minutes. The PET-CT scan involves lying flat and takes approximately 30 minutes to scan you from the top of your head to the middle of your thighs. The final PET-MRI scan will not require any further injections. This scan will go from the top of your head to the middle of your thighs and should take approximately 30 minutes. This scan is performed to directly compare the PET-CT images to the PET-MRI images. The images generated will be independently reviewed by trained Nuclear Medicine physicians partaking in the study to count the number of liver metastases. It is hoped that additional dynamic PET may further increase the sensitivity of detecting liver metastases. This may potentially influence treatment options in individual patients, including possibly avoiding futile surgery in patients with more extensive disease burden than detected on current standard imaging
Interventions
Each participant will receive a Ga-68-DOTATATE PET/MR and PET/CT Scan at Herston Imaging Research Facility (HIRF) on the same day.
Initial PET-MRI Scan
After emptying your bladder, a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called Ga-68-DOTATATE as well as a special dye called contrast.
The scan involves lying flat with knees supported and arms resting by your side. You will be s
Each participant will receive a Ga-68-DOTATATE PET/MR and PET/CT Scan at Herston Imaging Research Facility (HIRF) on the same day. Initial PET-MRI Scan After emptying your bladder, a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called Ga-68-DOTATATE as well as a special dye called contrast. The scan involves lying flat with knees supported and arms resting by your side. You will be scanned from the top of your head to the middle of your thighs. The scan time for the PET-MRI will be approximately 45 minutes. During this time the MR part of the scanner will make buzzing or knocking noises as it generates different kinds of images. PET-CT Scan You will be asked empty your bladder again and walk to the PET-CT scanner in the room next door. The PET-CT scan involves lying flat and takes approximately 30 minutes to scan you from the top of your head to the middle of your thighs. Final PET-MRI Scan After the PET-CT Scan, you will be asked to walk back to the PET-MRI scanner where a final PET-MRI will be performed. This scan will not require any further injections. This scan will go from the top of your head to the middle of your thighs and should take approximately 30 minutes. This scan is performed to directly compare the PET-CT images to the PET-MRI images.
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically proven WHO Grade I (defined as slowly proliferating tumors, measured on histology by a marker Ki-67 with value of <3%) to WHO Grade II (Ki-67 3-20%) NET with known liver metastases 2. Clinically requires Ga-68-DOTATATE PET-CT scan 3. Liver metastases on diagnostic CT 4. Written informed consent 5. All women of childbearing age must have a pregnancy test before enrolment
Exclusion criteria
1. Pregnant or breastfeeding 2. Life expectancy less than 6 months 3. Previously known non-Ga-DOTATATE avid disease. 4. Contraindication to MRI 5. Severe claustrophobia 6. Known renal impairment 7. Hypersensitivity to Primovist
Outcome results
None listed