No registrations found.
ID
Source
Brief title
Health condition
Rectal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
SUVmax, ADC
Secondary outcome
TLG, SUVmax change
Background summary
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.
Study objective
Combining digital FDG-PET/CT and DW-MRI imaging will more accurately predict and define response in rectal cancer patients after neoadjuvant treatment.
Study design
.
Intervention
Digital FDG-PET/CT, DW-MRI.
Inclusion criteria
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
Exclusion criteria
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)
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7563 |
| Other | METC LUMC : METC P18.023 |