The primary objective is to evaluate the feasibility of FDG-PET/MRI to improve tumor response assessment after nCRT compared to standard FDG-PET/CT.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is qualitative re-staging after nCRT based on
FDG-PET/MRI versus FDG-PET/CT, with pathology as gold standard (i.e.
histopathologic assessment of the resection specimen when patients undergo
surgery after nCRT, or histopathology/cytopathology of the primary tumor and
suspected (distant) metastases as obtained during standard follow-up when
patients do not undergo surgery or postpone surgery after nCRT).The other
primary study parameters to assess feasibility include: experienced burden of
undergoing FDG-PET/MRI, measurements of the primary tumor and lymph nodes,
quantitative measurements of standardized uptake values at the primary tumor
and suspected locoregional lymph nodes on FDG-PET/MRI compared to FDG-PET/CT,
and quantitative measurements of the apparent diffusion coefficient at the
primary tumor and suspected locoregional lymph nodes on FDG-PET/MRI.
Secondary outcome
Not applicable, since the study has one primary objective.
Background summary
FDG-PET/MRI is a new technique that combines simultaneous acquisition of an
18F-fluorodeoxyglucose positron emission tomography (FDG-PET) scan with a
magnetic resonance imaging (MRI) scan. FDG-PET/MRI has the potential to provide
better anatomical visualization compared to FDG-PET/computed tomography
(FDG-PET/CT), which is the current standard functional imaging modality used
for staging esophageal cancer. In addition, FDG-PET/MRI has the possibility to
provide functional information through MRI-specific parameters that quantify
cellular density in tissue, which has been shown relevant for tumor detection.
However, the potential utility of FDG-PET/MRI for response evaluation after
neoadjuvant chemoradiotherapy (nCRT) to facilitate and improve personalized
treatment yet needs to be determined. The hypothesis is that FDG-PET/MRI is
more accurate than FDG-PET/CT for re-staging after nCRT.
Study objective
The primary objective is to evaluate the feasibility of FDG-PET/MRI to improve
tumor response assessment after nCRT compared to standard FDG-PET/CT.
Study design
Single-center, cross-sectional observational feasibility study.
Study burden and risks
The main burden for patients participating in the present study involves
undergoing one additional FDG-PET/MRI scan immediately after a clinically
indicated FDG-PET/low dose CT scan. As such, no additional injection of the
radiotracer 18F-FDG will be necessary. As part of this study, the FDG-PET/low
dose CT examination will be combined with a contrast-enhanced diagnostic CT
scan. The diagnostic CT scan will add 5 minutes to the standard FDG-PET/low
dose CT procedure. For a patient of 70 kilograms, the radiation exposure of the
standard protocol neck/thorax/abdomen diagnostic CT scan is approximately 12
mSV. Contrast medium will be administered before start of diagnostic CT
according to standard clinical care. In rare cases of an unknown allergy, this
might cause a severe contrast allergy reaction, for which patients are strictly
monitored and if necessary treated for according to standard clinical care.
FDG-PET/MRI scanning may cause hinder of noise, fatigue, sensations of warmth
and feelings of claustrophobia. To avoid danger due to carrying metal objects
in the area of the magnetic field, patients are strictly screened for having
any metal objects in or on the body before entering the area of the FDG-PET/MRI
scanner. Patients will not be exposed to risks of injection of additional
tracers other than required for the clinically indicated FDG-PET/CT scan. We
expect that FDG-PET/MRI provides a benefit in the re-staging of esophageal
cancer, especially in the case of inconclusive FDG-PET/CT findings, thus
avoiding additional other examinations. On the other hand, it is also possible
that FDG-PET/MRI will provide discordant findings, the value of which is the
subject of research in the present project, necessitating further examinations
for the patient.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Age *18 years;
- Histologically proven esophageal adenocarcinoma or squamous cell carcinoma
located caudally to the carina;
- Completed neoadjuvant chemoradiotherapy (nCRT);
- Scheduled to undergo FDG-PET/CT at 4-6 weeks after nCRT or at 8-12 weeks
after nCRT as part of standard clinical care.
Exclusion criteria
- Contra-indications for MRI (e.g. pacemaker, metal implant, claustrophobia);
- Contra-indications for iodinated contrast media (e.g. previous
contrast-allergy or eGFR <30 ml/min/1,73m2);
- FDG-nonavid tumor as determined from the pre-treatment PET/CT scan;
- Incapacitated patients, prohibiting the understanding and giving of informed
consent and to complete the questionnaire on experienced burden with PET/MRI.
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 | NL75204.078.20 |
| OMON | NL-OMON28571 |