Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Percy LEE

Description

Summary

feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

Details

feasibility of using a diffusion sequence of a MRgRT system as an early marker of treatment response during nRCT of rectal adenocarcinoma.

Keywords

Rectal Adenocarcinoma, Diffusion weighted imaging, Radiation therapy, Adenocarcinoma, Rectal Neoplasms, MRI-guided radiotherapy by on-board DWI sequences

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patient over 18 years old.
  2. Diagnosis of histologically confirmed rectal adenocarcinoma for which nRCT has been indicated.
  3. Karnofsky Index (KPS) ≥ 70 or ECOG = 0 or 1
  4. Signed consent to participation.
  5. For women of childbearing age, effective contraception must also be agreed for the duration of treatment.
  6. Affiliation to a social security regimen, or beneficiary of such a regimen.

You CAN'T join if...

  1. Predominant mucinous component on initial MRI, biopsy and / or definitive pathology. Mucin may lead to overestimation of ADC values on DWIs.
  2. Contraindications to the MRI procedure (non compatible pacemaker or other metallic foreign body, severe claustrophobia).
  3. Exclusive radiation therapy.
  4. Other associated neo-adjuvant treatment.
  5. Delayed completion of the surgery (more than approximately 10 weeks after the end of the nRCT) or cancellation of the surgical procedure.
  6. Contraindications to capecitabine: Severe hepatic impairment, severe renal impairment (creatinine clearance <30 ml / min),
  7. Known deficiency of Dihydropyrimidine dehydrogenase (DPD), known hypersensitivity to 5-FU / capecitabine and / or its excipients.
  8. Participation in a protocol with concurrent treatment.
  9. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding
  10. Person in emergency situation, person of legal age subject to a legal protection measure, or unable to express his / her consent.
  11. Impossibility of attending the medical examination of the test for geographical, social or psychological reasons.

Locations

  • University of California Los Angeles (UCLA) not yet accepting patients
    Los Angeles California 90095-1406 United States
  • Institut Paoli Calmettes accepting new patients
    Marseille Bouches Du Rhone 13009 France

Lead Scientist at UCLA

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Institut Paoli-Calmettes
ID
NCT03961776
Study Type
Observational
Participants
Expecting 39 study participants
Last Updated