BioXmark, Rectal Feasibility Trial

September 3, 2019 updated by: Maastricht Radiation Oncology

BioXmark Liquid Fiducials to Enable Radiotherapy Tumor Boosting in Rectal Cancer, a Feasibility Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective non-randomized open label trial.

A total of 20 patients who will undergo neo-adjuvant chemo-radiotherapy for rectal cancer will be included in this study upon informed consent.

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).

Participants will undergo standard treatment for their rectal cancer.

As part of standard patient set-up directly before each radiotherapy treatment, kilovoltage (KV) cone-beam computed tomography (CBCT) 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 (this probe will be positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum). Moreover, 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 Magnetic resonance imaging (MRI) of the rectum will be made for response evaluation 6-8 weeks after the end of neo-adjuvant chemo-radiotherapy.

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.

Cone-beam CT and MR images which are obtained as routine practice during treatment of the participants will be compared with images of 20 non-participating patients treated at our institute in the same period.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 NA
        • Maastro clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BioXmark liquid fiducial markers
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
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).
Other: Imaging

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.

Procedure: surgery or wait-and-see
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positional stability of BioXmark liquid fiducial markers during the treatment course
Time Frame: will be determined through the course of radiotherapy, an average of 5 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visibility/visual stability of BioXmark liquid fiducial markers during the treatment course
Time Frame: will be determined for the time interval between placement and the post-treatment MRI, an average of 12 weeks
Visual stability will be evaluated by scoring visibility of the markers on CT, CBCT, EPI and MRI (T1, T2 and diffusion weighted images) by 2 independent observers using a subjective scoring system: 0 = not visible, 1 = barely visible, 2 = clearly visible.
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
Time Frame: will be determined for the time interval between placement and pretreatment radiotherapy planning CT, an average of 1 week
(1 - number of markers visible on the last CBCT (cone-beam computed tomography) during treatment / number of visible markers at pCT) * 100
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
Time Frame: will be determined for the time intervals through the course of radiotherapy, an average of 5 weeks
(1 - number of markers visible on the last CBCT (cone-beam computed tomography) during treatment / number of visible markers at pCT) * 100
will be determined for the time intervals through the course of radiotherapy, an average of 5 weeks
Adverse events (AE) potentially associated with BioXmark
Time Frame: until rectal surgery, on average 11 weeks, or in case of omission of surgery, until 3 months after marker placement.
The safety of bioXmark liquid fiducials placement will be assessed by recording 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.
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
Time Frame: through the course of radiotherapy, an average of 5 weeks
The concordance index (CI) of gross tumor volume (GTV) localization between observers on kV CBCT will be determined. The CI is the ratio of the intersection and the union of the two volumes.
through the course of radiotherapy, an average of 5 weeks
Effect of BioXmark liquid fiducial markers on post-treatment MRI images
Time Frame: at the moment of the post-treatment MRI, on average 6-8 weeks after chemo-radiation
Potential BioXmark induced artefacts will be scored by 2 independent observers using a subjective scoring system:
at the moment of the post-treatment MRI, on average 6-8 weeks after chemo-radiation
Potential BioXmark induced alterations in the surgical specimen
Time Frame: on average 10-12 weeks after chemo-radiation

The surgical specimens will be evaluated for signs of marker-induced alterations.

Potential BioXmark induced alteration in the surgical specimen will be scored by 2 independent observers using a subjective scoring system.In case the markers can't be located in the surgical specimen standard clinical evaluation of the specimen will take place. If the marker got lost during tissue processing potential inflammation/perforation will be scored as follows:A) 0 = no signs of extra inflammatory changes possibly related to the fiducials, 1 = limited extra inflammatory changes possibly related to the fiducials, 2 = severe extra inflammatory changes possibly related to the fiducials; B) 0 = no perforation of the rectal possibly related to fiducials, 1 = perforation of the rectal possibly related to the fiducials
on average 10-12 weeks after chemo-radiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Investigators

  • Principal Investigator: Maaike Berbée, MD,PhD, Maastro Clinic, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2018

Primary Completion (ACTUAL)

July 25, 2019

Study Completion (ACTUAL)

July 25, 2019

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (ACTUAL)

August 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 4, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W 16 09 00091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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