We aim to determine the added value of a direct FET-PET for clinical practice. The hypothesis is that the addition of FET-PET will lead to correct diagnosis more rapidly than regular MRI alone, and thus to a better quality of life for patients…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. The percentage of patients undergoing unnecessary interventions: diagnostic
biopsies, surgeries, medications.
2. Health related quality of life (EQ5D, EORTC-QLQ-BN20, iPCQ and iMCQ) at 12
weeks
Secondary outcome
-Time-to-diagnosis (defined as index MRI to final
treatment)
-Overall survival (defined from index
MRI)
-Number of unnecessary treatment
cycles
-Cost-effectiveness in QALYs and ICERs
-HRQOL (continuous measure): EQ5D,
EORTC-QLQ-BN20, iPCQ and iMCQ at 6 weeks and 6
months
Background summary
Glioblastoma patients undergo postoperative chemoradiation. During follow-up,
there is often an increase in MRI abnormalities, and distinguishing between
tumor growth and damage as a result of the treatment ('pseudoprogression') is
difficult. Techniques such as perfusion MRI can provide additional information,
but uncertainty often remains, which can lead to incorrect or delayed
diagnosis, leading to uncertainty, unnecessary treatment - even unnecessary
surgery - or delay of adequate treatment. A new type of scan, the [18F]
FET-PET, has a good discriminating power between pseudoprogression and tumor
growth, but is still used infrequently due to costs, extra logistics, and doubt
about clinical benefit.
Study objective
We aim to determine the added value of a direct FET-PET for clinical practice.
The hypothesis is that the addition of FET-PET will lead to correct diagnosis
more rapidly than regular MRI alone, and thus to a better quality of life for
patients through earlier certainty, faster initiation of the adequate policy,
fewer unnecessary examinations and treatments; and to a net decrease in
healthcare costs.
Study design
Multicenter diagnostic randomized clinical trial.
Intervention
The use of FET-PET (in addition to MRI) to differentiate between tumor growth
and
pseudoprogression.
Study burden and risks
FET PET is already implemented in daily clinical practice in some centers, with
an associated negligible risk. Moreover, undergoing an additional PET scan and
the completion of questionnaires is perceived as a relatively low and
acceptable burden. This assessment considers the potential positive impact of
FET PET on the individual participant.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Patients with a glioblastoma, IDH-wildtype, WHO grade 4, according to WHO
2021 criteria. - Age >=18
years
- New or increased enhancement within the high-dose
radiation field (defined as within the 80% isodose line) on follow-up
MRI
- Follow
up MRI >=3 months after the end of the standard-of-care temozolomide-based
concomitant chemoradiation (short- and long course). Of note, very early
increase - within 3 months of last radiation - will not be grounds for
inclusion because of the high rate of pseudoprogression and slightly lower
diagnostic performance of FET-PET compared to the situation of increase beyond
3 months after last radiation. Patients with such very early increase may have
subsequent further increase after 3 months post-radiation, causing (further)
diagnostic doubt; these may be included at that later timepoint if they meet
the other inclusion
criteria.
- First moment of clinicoradiological uncertainty regarding
the diagnosis (>=3 months after the end of chemoradiation): pseudoprogression or
tumor recurrence. The determination of *uncertainty* is made by the treating
physician, preferably in the multidisciplinary tumor board, based on available
clinical and standard-of-care MRI-data, which generally includes
perfusion-MRI. - Previous
usage of bevacizumab as a symptom treatment is allowed. However, inclusion is
only allowed at the first moment of clinical doubt between pseudoprogression
and tumor recurrence, not at later timepoints.
Exclusion criteria
- Previous treatment for recurrence of disease
- An enhanced lesion size of less than 1 cm on the index MRI. In the newest
RANO PET-criteria, it is advised to use FET-PET for increasing lesions only in
cases with a minimum lesion size.
- Life expectancy of less than 6 months, determined by the treating physician
- Contra-indications for PET (claustrophobia, inability to lay still)
- Women of childbearing potential without adequate contraception
- Any other concomitant disease that may influence PET imaging or clinical
outcomes of this study, this includes but is not limited to: cerebral
inflammatory diseases and other cancers with brain- or leptomeningeal
metastases.
Design
Recruitment
Medical products/devices used
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 | NL86008.041.24 |