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Investigating new imaging criteria for non-operative treatment following neoadjuvant chemoradiation in rectal cancer patients

Investigating new imaging criteria for non-operative treatment following neoadjuvant chemoradiation in rectal cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22673
Enrollment
20
Registered
2019-03-03
Start date
2018-08-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Digital FDG-PET/CT, DW-MRI.

Sponsors

Leiden Unversity Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
SUVmax, ADC

Secondary

MeasureTime frame
TLG, SUVmax change

Contacts

Public ContactFloris Vuijk

Leiden University Medical Center

f.a.vuijk@lumc.nl071-5265130

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)