Anatomical and functional magnetic resonance imaging (MRI) are of additional value to combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (PET-CT) in the evaluation of treatment response to neoadjuvant chemoradiation…
ID
Bron
Verkorte titel
Aandoening
Esophageal cancer.
MRI.
PET-CT.
Oesofaguscarcinoom.
Slokdarmkanker.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The additional diagnostic value -in terms of accuracy, sensitivity, specificity and predicitve values- of anatomical and functional MRI to PET-CT in the evaluation of treatment response to neoadjuvant chemoradiation therapy for patients with esophageal cancer, as compared to the pathological specimen as gold standard.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Anatomical and functional magnetic resonance imaging (MRI) are of additional value to combined 18F-fluorodeoxyglucose positron emission tomography and computed tomography (PET-CT) in the evaluation of treatment response to neoadjuvant chemoradiation therapy for patients with esophageal cancer.
Onderzoeksopzet
1. Pre-chemoradiation: MRI and PET-CT;
2. 2 weeks after start of chemoradiation: MRI and PET-CT;
3. 1-2 weeks prior to surgery: MRI and PET-CT.
Onderzoeksproduct en/of interventie
1. Three MRI scans: Pre-, per- and post-chemoradiation therapy;
2. Three PET-CT scans: Pre-, per- and post-chemoradiation therapy.
Algemeen / deelnemers
[default]
The Netherlands
Wetenschappers
[default]
The Netherlands
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Histologically confirmed carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy);
2. Potentially resectable tumor (cT1b-4a N0-3 M0);
3. Undergoing neoadjuvant chemoradiation according to CROSS-regimen;
4. Age >18 years;
5. No history of other cancer or previous radiotherapy or chemotherapy;
6. Signed informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Patients who meet exclusion criteria for MRI at 1.5T following the protocol of the Radiology department of the UMC Utrecht;
2. Glomerular Filtration Rate (GFR) of <45 mL/min/1.73m2, unless the patient has risk factors for contrast nefropathy according to the UMC Utrecht protocol ‘Preventie contrastreactie en contrast nefropathie, Versie 2 februari 2012’. In patients with risk factors a minimum GFR of 60 mL/min/1.73m2 will be required;
3. Patients with insulin dependent diabetes mellitus or a blood plasma glucose concentration higher than 10 mmol/L;
4. Patients with a known Gadovist allergy;
5. Patients with a known CT-contrast allergy;
6. Patients having difficulty understanding Dutch;
7. Pregnant or breast-feeding patients.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3816 |
| NTR-old | NTR3981 |
| Ander register | CCMO : 42022.041.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |