None listed
Conditions
Brief summary
This study is examining whether inserting gold markers (known as fiducial markers) into a tumour may aid surgical and chemotherapy response assessment in patients with oesophageal-gastric cancer. Who is it for? You may be eligible to join this study if you are aged over 18 years and have been diagnosed with biopsy proven primary (non-recurrent) squamous cell carcinoma (SCC) or adenocarcinoma of the stomach. Trial details: All participants in this trial will have 2-4 tiny gold markers (known as fiducial markers) inserted into the tissue beside their tumour during endoscopy. Endoscopy involves having a tube inserted into the back of the throat and takes about 30 minutes. Each gold marker is approximately the size of a grain of rice (1mm x 3mm). Having gold seed locators makes it easy for the surgeon or the radiotherapist to know exactly where to operate or irradiate because they show up clearly on the PET Scan, CAT Scan and Radiation Treatment machine. If the tumour shrinks very well with chemotherapy then the Pathologist may not know exactly where to find the tumour in the tissue removed. This can make it very difficult to provide a precise report and hence the need for any follow-up treatment after surgery. This study will not affect routine treatment in any other way. We wish to study approximately 20 patient’s scans and pathology reports to see exactly how much improvement we get in correlating these gold markers with scan results. At the moment there is no good information to show that they consistently improve accuracy of treatment for stomach and oesophageal tumours. We have good information over the last 40 years that gold marker seeds improve accuracy in Head and Neck Cancer and Cervical Cancer. Over the last 10 years they have become indispensable in Breast Cancer (titanium markers rather than gold) and particularly in prostate cancer radiotherapy, where gold seeds have reduced radiotherapy side effects massively in tens of thousands of men worldwide. Based on this information we expect that there will be benefits in the stomach and oesophagus as well.
Interventions
Endoscopic ultrasound guided insertion of markers known as fiducials (inert gold markers) to delineate the tumour for the purpose of monitoring treatment response and anatomical localisation.
The markers are inserted into the superior/inferior margins of the tumour and if possible into the lateral margins. Therefore a total of between 2-4 tiny gold markers will be inserted. The duration of the enitre procedure including EUS staging is approximately 30 minutes.
Sponsors
Austin Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Age>18yrs with biopsy proven primary (non-recurrent) squamous cell carcinoma (SCC)or adenocarcinoma of the stomach discussed at the upper gastro-intestinal multidisciplinary team meeting (MDT) were considered eligible if they fulfilled the inclusion criteria. These criteria included cancer stage (T1-3,N0-1,M0-1a), ECOG 0 or 1, medically suitable for oeosphagectomy and chemotherapy and or chemoradiotherapy, and written informed consent.
Exclusion criteria
Stage M1b Contraindications to CT contrast e.g. severe chronic kidney disease, allergy to contrast Contraindications to PET/CT e.g. claustrophobia
Outcome results
None listed