to determine the diagnostic value of digital PET/CT as a staging and restaging imaging modality, as compared with ceCT and Ca 19.9, in patients with (borderline) resectable pancreatic cancer
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic value (sensitivity, specificity, accuracy) of digital PET/CT for
staging and response assessment
Secondary outcome
Correlation of staging data and restaging data with tumor marker CA 19.9 serum
levels.
Background summary
For pancreatic cancer, surgery is the only treatment method that can
potentially cure the patient. Currently only 20% of the patients are eligible
for a surgical resection with curative intention. A recent development in
pancreatic cancer treatment is the use of neo-adjuvant chemotherapy before
surgery and this has already shown good clinical results. In these patients,
contrast-enhanced Computed Tomography scans (ceCT) of the abdomen are acquired
for (re)staging. However, response evaluation with CT scans is unreliable
because it is not possible to distinguish between post-treatment fibrosis and
malignancies. Recently, a novel digital PET system was introduced in Isala,
which provides PET images that are significantly more detailed and accurate as
compared to the analog PET systems. Furthermore, the tumor marker Serum Ca 19.9
is widely used for pancreatic adenocarcinoma and has shown its value in the
assessment of response to neo-adjuvant therapy. The aim of this study is to
evaluate the diagnostic value of digital PET/CT as a staging and restaging
imaging modality, as compared with ceCT and Ca 19.9, in patients with
resectable or borderline resectable pancreatic cancer, who are treated with
neo-adjuvant therapy before surgery.
Study objective
to determine the diagnostic value of digital PET/CT as a staging and restaging
imaging modality, as compared with ceCT and Ca 19.9, in patients with
(borderline) resectable pancreatic cancer
Study design
Single center diagnostic accuracy study using intra-individual comparisons of
FDG-PET/CT scans and ceCT scans
Study burden and risks
• Additional wait time and scan time: For each patient included in this study,
two FDG-PET/CT scans will be performed in a four months* time period. Before
injection of FDG, patients have to be sober for at least 6 hours. After
intravenous injection of FDG, the patient has to lie down for approximately 50
minutes in a separate room, before the PET/CT acquisition will start.
Furthermore, the PET/CT acquisition itself will take on average 20 to 30
minutes, including performing the attenuation CT, in which the patients have to
lie still on a scanner bed.
• Additional radiation dose: The two study-related FDG-PET/CT scans will give
an additional radiation dose of on average 8 milliSievert (mSv), per scan. In
comparison: for the diagnostic ceCT that is routinely performed multiple times
in pancreatic cancer patients, the average dose is 14 mSv.
Dokter van Heesweg 2
Zwolle 8025AB
NL
Dokter van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Histological or cytological confirmed malignant peri-ampullary tumour, resectable or borderline resectable, without evidence of distant metastases.
• Inclusion in the Preopanc-2 study and randomized for neo-adjuvant chemotherapy
• Written informed consent
There is an additional inclusion criterion for the acquisition of the second FDG-PET/CT scan: only patients that are treated with at least 4 cycles, and a maximum of 8 cycles of neo-adjuvant chemotherapy will be referred for this FDG-PET/CT scan.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Age < 18 years
• Incapacitated adults
• Prisoners
• Pregnancy
• Unable to undergo a FDG-PET/CT scan
• Metastatic or locally advanced (i.e. unresectable) pancreatic cancer
• Ampullary or distal bile duct cancer.
• Prior radiotherapy, chemotherapy, or resection for pancreatic cancer.
• Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer.
• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64320.075.17 |
| OMON | NL-OMON22880 |