To determine the test-retest variability of quantitative hypoxia imaging with FAZA-PET, both in untreated subjects (track A) and during radiotherapy (track B). The purpose of this study is to validate FAZA-PET as a selection criterion for…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Test-restest variability of FAZA-PET quantification (as a percentage with 95%
conficence interval).
Secondary outcome
Not applicable.
Background summary
Low oxygen levels in tumor tissue (hypoxia) is an important adverse factor in
radiotherapy of head-neck tumors. Hypoxia can be visualized quantitatively with
the PET-tracer fluor-18-*uoroazomycin-arabinoside (FAZA). This makes FAZA-PET a
potential instrument for selection of hypoxia-modulating strategies, that could
improve the response to radiotherapy in the presence of hypoxia. Currently the
normal variations in (FAZA-PET imaging of) tumor hypoxia are unknown. This
hinders determination of thresholds for detection of significant hypoxia, and
for detection of significant changes therein as induced by hypoxia modulation.
Study objective
To determine the test-retest variability of quantitative hypoxia imaging with
FAZA-PET, both in untreated subjects (track A) and during radiotherapy (track
B). The purpose of this study is to validate FAZA-PET as a selection criterion
for application of hypoxia-modulating strategies, and as a tool to determine
the effectiveness of these strategies prior to and during radiotherapy.
Study design
Repeated quantitative hypoxia imaging (2 times) without intevention (track A)
and during radiotherapy (track B). Analysis of the test-retest variability.
Study burden and risks
Patient burden: 2 FAZA-PET/CT scans, with per scan: placement of an intravenous
catheter, injection of 190-240 MBq F-18-FAZA (estimated 7 mSv), 15 min dynamic
PET acquisition and 15 min static PET acquisition in a total time range of 2
hours. Lowdose CT for attenuation correction of the PET signal (estimated 1 mSv
per acquisition), thus a total radiation burden per FAZA-PET/CT scan of about 9
mSv. This is well within the range of normal diagnostic imaging. The risk of
this radiation exposure is negligible relative to the subsequent radiotherapy
with curative intent.
Plesmanlaan 121
1066 CX
Nederland
Plesmanlaan 121
1066 CX
Nederland
Listed location countries
Age
Inclusion criteria
Histology proven oropharyngeal cancer, stage III or IV, any grade, eligible for RADPLAT.
Exclusion criteria
Pregnancy
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 | NL22153.031.08 |