Combining digital FDG-PET/CT and DW-MRI imaging will more accurately predict and define response in rectal cancer patients after neoadjuvant treatment.
ID
Bron
Verkorte titel
Aandoening
Rectal cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
SUVmax, ADC
Achtergrond van het onderzoek
A single-arm multicentre pilot study to assess the feasibility of combining digital FDG-PET/CT and (DW-)MRI in predicting response to neoadjuvant chemoradiation in patients with locally advanced rectal cancer.
Doel van het onderzoek
Combining digital FDG-PET/CT and DW-MRI imaging will more accurately predict and define response in rectal cancer patients after neoadjuvant treatment.
Onderzoeksopzet
.
Onderzoeksproduct en/of interventie
Digital FDG-PET/CT, DW-MRI.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Biopsy proven adenocarcinoma of the rectum
Patients with locally advanced rectal cancer who, according to current guidelines, are eligible for treatment with neoadjuvant chemoradiation
Patients treated in the LUMC, HMC, Alrijne Leiderdorp or Groene Hart Ziekenhuis Gouda.
Age 18 years and older;
Willing to participate in all aspects of the study
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients with rectal cancer, receiving chemoradiation as part of the TESAR trial
Diabetes mellitus
Claustrofobia (low dose benzodiazepines are allowed)
Prior radiotherapy to the pelvis
If female and fertile: signs and symptoms of pregnancy or a positive pregnancy test / breast-feeding (a formal negative pregnancy test is not obligatory
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Contraindications for Magnetic Resonance Imaging
Patient has evidence of infection in the 14 days prior to the FDG-PET/CT scan localised to the lower abdomen, pelvic region, lower back, inguinal region
Inability to tolerate lying supine for the duration of an FDG-PET/CT examination (~30min)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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 | NL7563 |
Ander register | METC LUMC : METC P18.023 |