BioXmark, Rectal Feasibility Trial

NCT03265418 | Completed DMC

• 1 other identifier: W 16 09 00091
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To test the feasibility and accuracy of BioXmark fiducial markers for image guided radiotherapy (IGRT) based rectal tumor boosting in 20 patients referred for long course chemo-radiotherapy of the locally advanced rectal cancer.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Positional stability of BioXmark liquid fiducial markers during the treatment course

  Positional stability / potential marker migration will be assessed by calculating marker pair distances.

  will be determined through the course of radiotherapy, an average of 5 weeks

Secondary Outcomes (7)

• Visibility/visual stability of BioXmark liquid fiducial markers during the treatment course

  will be determined for the time interval between placement and the post-treatment MRI, an average of 12 weeks

• Percentage of markers lost from injection to CT acquisition for RT planning

  will be determined for the time interval between placement and pretreatment radiotherapy planning CT, an average of 1 week

• Percentage of markers lost from injection to CT acquisition for RT planning

  will be determined for the time intervals through the course of radiotherapy, an average of 5 weeks

• Adverse events (AE) potentially associated with BioXmark

  until rectal surgery, on average 11 weeks, or in case of omission of surgery, until 3 months after marker placement.

• Inter-observer variation in gross tumor volume (GTV) localization with and without markers

  through the course of radiotherapy, an average of 5 weeks

Study Arms (1)

BioXmark liquid fiducial markers

EXPERIMENTAL

Placement of 4 BioXmark liquid fiducial markers, standard treatment (chemo-radiotherapy followed by surgery or wait-and-see) with extra imaging to evaluate the behaviour of the markers before, during and after the radiotherapy

Device: BioXmark liquid fiducial markers; Other: Imaging; Procedure: surgery or wait-and-see

Interventions

BioXmark liquid fiducial markers DEVICE

Before the start of the treatment planning during an extra sigmoidoscopy after enema preparation, 4 liquid marker spots will be placed 1 cm from the tumor; two in the in the cranial and two in the caudal direction of the tumor (4 markers in total per patient).

BioXmark liquid fiducial markers

Imaging OTHER

As part of standard patient set-up directly before each radiotherapy treatment, kV cone-beam CTs will be acquired. Treatment positioning will be based on the regular clinical decision protocols for treatment of rectal cancer and not on the markers. During treatment potential fiducial movement will be assessed using an externally positioned ultra-sound probe, positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum. For patients in this study 2 orthogonal kV images will be made immediately after each radiation using the electronic portal imaging (EPI) device. As part of standard clinical practice an MR of the rectum will be made for response evaluation 6-8 weeks after the end of neo-adjuvant chemo-radiotherapy.

BioXmark liquid fiducial markers

surgery or wait-and-see PROCEDURE

As part of standard clinical practice patients whose tumor has not responded completely will be operated on 8-12 weeks after the end of neoadjuvant chemo-radiotherapy. Patients with a complete response will be follow-upped according to the "wait-and-see" protocol.

BioXmark liquid fiducial markers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histological or cytological proven adenocarcinoma of the rectum, treated with long course external beam radiotherapy
• Age \> 18 years
• Have given written informed consent before patient registration

You may not qualify if:

• Patients using anticoagulants: platelet aggregation inhibitors or coumarines
• Iodine allergy

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

Study Sites (1)

MAASTRO Clinic

Maastricht, Limburg, 6202 NA, Netherlands

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

X-Rays; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Maaike Berbée, MD,PhD

  Maastro Clinic, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: August 29, 2017
• Study Start: January 2, 2018
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)