Primary: How does the diagnostic outcome of the digital PET/CT study compare to the outcome of conventional PET/CT in patients referred for (re)staging of lung cancer, breast cancer and a group of miscellaneous cancers?Secundary: What is the image…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Final result of the PET/CT study. This outcome parameter includes multiple
parameters, such as the number of regional lymph nodes, the number of distant
metastasis and the final TNM classification.
Secondary outcome
PET image quality. This outcome parameter includes multiple parameters, such as
the image noise, diagnostic confidence and lesion detectability
(contrast-to-noise etc.).
Background summary
FDG-PET/CT imaging is important for staging, response monitoring and prognosis
prediction in patients with cancer. However, the spatial resolution of current
PET/CT systems is relatively low, limiting the detection of small lesions and
accurate staging. In 2017, a very novel state-of-the-art digital PET/CT system
will be installed at the NM department in Isala. It is expected that this new
type of scanner contributes to more accurate staging and possibly more
effective patient management. For a period of 6-12 months, both a conventional
and a digital PET/CT system will be available in the NM department in Isala.
This provides the unique possibility to evaluate the performance of the digital
PET/CT system compared with conventional PET/CT. In this study, we will analyze
the impact of digital PET/CT on the final diagnostic conclusion of the scan in
patients with lung cancer, breast cancer and a group of miscellaneous cancers.
Study objective
Primary: How does the diagnostic outcome of the digital PET/CT study compare to
the outcome of conventional PET/CT in patients referred for (re)staging of lung
cancer, breast cancer and a group of miscellaneous cancers?
Secundary: What is the image quality (in both quantitative and qualitative
terms) of digital PET as compared to conventional PET?
Study design
Single center diagnostic accuracy study
Intervention
not applicable
Study burden and risks
*Additional scan time: Immediately after acquisition of the first clinical
PET/CT study, a second PET/CT study will be obtained. The additional time in
the second PET/CT scanner will typically be 25 minutes (maximum 40 minutes), in
which patients have to lie still on a scanner bed.
*Additional radiation dose: In a standard clinical FDG-PET/CT scan, the average
dose is 14 milliSievert (mSv). This consists of the dose from a low-dose CT
scan for attenuation-correction and the dose from FDG. In several cases, an
additional CT-scan with intravenous contrast is acquired for diagnostic
purposes, leading to a total radiation dose of averagely 22 mSv. In comparison:
the extra study-related low-dose CT scan will give an additional radiation dose
of on average 6 mSv. The total dose is body-weight dependent.
Miner Road 595
Cleveland 44143
NL
Miner Road 595
Cleveland 44143
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:
* referred for a clinically indicated FDG-PET/CT scan
* suspected or proven lung cancer, breast cancer and a group of miscellaneous cancers
* signed informed consent
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
* pregnant woman
* not able to undergo two consecutive PET/CT scans
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52329.075.15 |