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NCT Number: NCT04927897

DETECT: Target Volume for Rectal Endoluminal Radiation Boosting

The aim of the study is to provide prospective data regarding microscopic tumor spread in all directions from the macroscopic tumor in pathology specimens, as seen by eye, and on imaging to define the target volume for endoluminal radiation boosting in rectal cancer patients.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center, Maastricht, Limburg, Netherlands

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About this study

This study is a prospective multicentre cohort trial in ≥50 patients with a residual ycT1-3N0 tumor after neoadjuvant chemoradiotherapy or radiotherapy for rectal adenocarcinoma at least 6 weeks after the neoadjuvant treatment.

In addition to standard workup and treatment (e.g. a flexible endoscopy and an MRI scan at 6-8 weeks post-neoadjuvant therapy), patients will undergo pre-operatively, after induction of general anaesthesia, an endorectal ultrasound and rigid rectoscopy as study procedures if these procedures are not already part of standard workup. Furthermore, the pathological specimens of some patients will be scanned using MR imaging during certain parts of the pathological process.

Objectives include determining the maximum distance of microscopic tumor spread per patient in all directions, creating a tissue deformation model to account for changes due to e.g. fixation and pathological processing, using this tissue deformation model to translate the microscopic tumor spread back to the in vivo situation (e.g. back to in vivo MRI scans, 3D endo-ultrasounds), and evaluating/determining risk factors for the presence and/or extent of microscopic tumor spread.

This data will be used for target volume definition in rectal endoluminal radiation boosting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age and capable of giving informed consent.
  • ycT1-3N0(*) residual(**) histology confirmed rectal adenocarcinoma after neoadjuvant radiotherapy or long-course chemoradiotherapy for which patients will undergo TME surgery.
  • Minimal interval between end of neoadjuvant chemoradiotherapy or radiotherapy: 6 weeks.

(*)= as determined by clinical assessment (digital rectal examination, endoscopy with or without biopsy) and/or MRI. Biopsy/histology around the time of diagnosis is adequate; no biopsy/histology is needed after neoadjuvant therapy.

(**)= including tumor regrowths/local recurrence after an initial clinical complete response and a "watch and wait" approach. These patients will also be included after the local recurrence has been determined using endoscopy and/or MRI.

Exclusion criteria

  • Patient has received brachytherapy as part of neoadjuvant treatment.
  • <18 years of age or incapable of giving informed consent.
  • Patient has not been treated with neoadjuvant radiotherapy or long-course chemoradiotherapy.
  • Patient will not undergo TME surgery for a ycT1-3N0 residual histology confirmed rectal adenocarcinoma.
  • Interval between end of neoadjuvant therapy and surgery is <6 weeks.

Treatment and study plan

Ultrasound

Diagnostic Test

3D endorectal ultrasound.

Rectoscopy

Diagnostic Test

Rigid rectoscopy.

Scan, e.g. CT (resection specimen)

Other

For some patients, images of the resection specimen (note: NOT of the patients) during the pathological process will be acquired.

Primary outcomes

  1. Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen

    Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)

    The maximum distance of microscopic tumor spread in all directions from the macroscopic remnant in the specimen will be measured per patient in millimeters by the pathology department in the pathologic resection specimens.

Secondary outcomes

  1. Maximum distance of microscopic tumor spread per patient from the macroscopic tumor remnant in the pathology specimen, reported separately for MTS perpendicular to the bowel wall and for MTS parallel to the bowel wall

    Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)

    Measured per patient in millimeters by the pathology department in the pathologic resection specimens. Microscopic tumor spread perpendicular to the bowel wall and parallel to the bowel wall will be reported separately.

  2. Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen excluding ypT0 patients

    Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)

    Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported excluding all ypT0 patients.

  3. Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen only including patients with microscopic tumor spread

    Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)

    Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported only for patients with microscopic tumor spread.

  4. Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant in the pathology specimen only for patients with regrowths

    Time frame: During post-resection pathological analysis (i.e. approximately 14 days post-resection)

    Measured per patient in millimeters by the pathology department in the pathologic resection specimens. For this secondary outcome, this will be reported only for patients with regrowths.

  5. Tissue deformation factor/model to compensate for tissue deformation due to removal of the specimen from the body, formalin fixation and tissue processing at the pathology department

    Time frame: The tissue deformation model will be created once all required data (e.g. MRI scans, rectoscopy images, endorectal ultrasound images) is available (approximately 14 days post-surgery for the final included patient).

    The deidentified images of the flexible endoscopy and in vivo MRI scan will be collected for the study. During the certain parts of the pathologic process, e.g. before and after fixation, MRIs of the pathological specimens of some of the patients will be made. These deidentified images of the specimens, together with e.g. the deidentified endoscopic, rectoscopic, ultrasound and in vivo MR images and possibly with optical images taken during pathological analysis, will be used to develop the deformation model.

    The flexible endoscopy and in vivo MRI scan are both taken approximately 6-8 weeks post-neoadjuvant treatment. The images of the rigid rectoscopy and 3D endorectal ultrasound are taken directly before TME surgery.

  6. Maximum distance of microscopic tumor spread per patient in all directions from the macroscopic tumor remnant as seen by eye and/or on imaging

    Time frame: When the tissue deformation model is finished (approximately 3 months after all data for every patient is available). For the imaging time frames: please refer to the description.

    The tissue deformation factor/model and the location of the microscopic tumor spread in relation to the macroscopic remnant determined during pathological analysis, will be used to determine the maximum distance of microscopic tumor spread in relation to the macroscopic tumor as seen by eye (rectoscopically/endoscopically) and/or on imaging (endo-ultrasound, MRI) per patient in all directions.

    The flexible endoscopy and in vivo MRI scan are both taken approximately 6-8 weeks post-neoadjuvant treatment. The images of the rigid rectoscopy and 3D endorectal ultrasound are taken directly before TME surgery.

  7. Treatment margin (in the various directions) relative to the macroscopic tumor to cover 90% and 95% of all microscopic tumor spread

    Time frame: Once the microscopic tumor spread is determined for all patients (approximately 14 days post-surgery for the final included patient), the treatment margins will be calculated.

    Distance that covers the microscopic tumor spread in all directions in millimeters for 90 and 95% of patients, including 95% confidence intervals, both reported including and excluding ypT0 patients. Reported both by eye and on imaging, for which among others the tissue deformation model will be used.

  8. Evaluation of risk factors for the presence and/or the extent of microscopic tumor spread identified by the meta-analysis we performed

    Time frame: ypT stage is determined during post-resection pathological analysis (i.e. approximately 14 days post-resection). The time interval is determined at the day of surgery.

    These risk factors include pathological T stage after chemoradiation (ypT stage) and time interval between neoadjuvant chemoradiotherapy and surgery.

Other outcomes

  1. Identification of potential risk factors for the presence and the extent of microscopic tumor spread not yet identified by our meta-analysis

    Time frame: Most are determined during post-resection path. analysis (approx. 14 days post-resection). ycT stage is determined approx. 6-10 weeks post-neoadjuvant treatment (multidisciplinary team), in vivo imaging is done approx 6-8 weeks post-neoadjuvant treatment

    Potential risk factors include among others ycT stage, regrowths/local recurrence, diameter, predominant histologic grade, tumor regression score/grade (pathologically), vascular invasion, lymphatic invasion, perineural invasion, microsatellite instability (MSI) and parameters related to in vivo MR imaging.

  2. Analysis of (re)biopsy material

    Time frame: Biopsy material is obtained at time of diagnosis.

    This includes the biopsy material at time of diagnosis, and also the rebiopsy material for patients with tumor regrowths/local recurrence after an initial clinical complete response and a "watch and wait" approach. These (re)biopsies are a part of the standard diagnostic work-up. Part of this analysis will be performed during this study by reassessment of the histology of the biopsy material and/or if applicable the rebiopsy material.

Study contacts

Contact information is provided by the study sponsor or research team.

Evert Van Limbergen, MD, PhD

CONTACT

[email protected]

0031884455600

Maaike Berbée, MD, PhD

CONTACT

[email protected]

0031884455600

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Catharina Ziekenhuis Eindhoven
  • Maastricht University Medical Center

Registry information

Official study title

DETECT: Defining the Target Volume for Endoluminal Radiation Boosting in Patients With Rectal Cancer

Acronym: DETECT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2021
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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