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Feasibility Study of Navigated Endoscopy for the Placement of High Dose Rate Brachytherapy Applicators in the Esophagus and Lung

22 maj 2018 uppdaterad av: University Health Network, Toronto
The scope of this clinical trial is to assess the clinical feasibility of this procedure, optimize the protocol and perform an initial comparison of the positional accuracy of navigated endoscopy and applicator insertion versus the standard of care 2D fluoroscopy protocol.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

High dose rate brachytherapy is used in a limited number of esophagus and lung patients, often in combination with external beam radiation therapy. The procedure uses an applicator inserted into the lumen with the applicator connected to an automated "afterloader", a device with a radioactive brachytherapy source attached to a thick guide wire that positions the source within the applicator at set positions and times based on a treatment plan. Identification of the ideal applicator position is determined by white light endoscopy. With the endoscope in the lumen, fluoroscopic imaging can visualize the endoscope position. Temporary radio-opaque skin markers are placed on the patient's anterior surface under fluoroscopy imaging so that they align with the endoscope tip. The proximal and the distal ends of the target volume are marked in this manner by the surgeon stopping the endoscope at these positions. The endoscope is removed and the applicator inserted, with the positions of the applicator and "dummy" seeds (i.e. non-radioactive seeds used only for positioning purposes) aligned under fluoroscopy to match the skin markers. The procedure has 2 disadvantages: i. There is extra radiation dose to the clinical staff due to the fluoroscopy used to identify the source position.

ii. Visualization is only in 2D, which is inaccurate since it does not account for separations in the vertical direction and the angle of projection between the applicator and the so patient surface. Furthermore, any movement of the fluoroscopy device during the insertion leads to errors in visualization.

Medical applications of navigated endoscopy continue to grow, especially when used in combination with volumetricimaging for image-guided procedures. This feasibility study is aimed to use navigation endoscopy technology to overcome the disadvantages of the current practice and improve the overall process.

In the proposed protocol, applicator insertion, tracking and recording of the endoscope and applicator positions would enable placement of the applicator using 3D information, with greater accuracy and without extra radiation dose to the clinical staff. The tracking technology would be used to replace the use of radio-opaque skin markers; rather than placing these markers on the patient's skin, the location of the target volume boundaries would be noted by the tracker position within the endoscope. Applicator insertion would also be tracked, with the applicator positioning based on the location of the applicator relative to the previously recorded endoscope positions, including the locations of the distal and proximal ends of the target volume.

Studietyp

Interventionell

Inskrivning (Faktisk)

1

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Ontario
      • Toronto, Ontario, Kanada, M5G 2M9
        • Princess Margaret Cancer Centre

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Age ≥ 18 years
  • Primary or metastatic cancer including endoluminal disease of either the lung or the esophagus
  • Intention to treat using high dose rate brachytherapy as part of standard radiotherapy.
  • Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  • Contraindications to standard radiation therapy including pregnancy, lactation, connective tissue disorders, serious co-morbid illness
  • Concurrent illness or condition that precludes subject from undergoing endoscopy
  • Patient is unable to tolerate an hour and a half long procedure. Standard of care practice is no more than 1 hour. However, with the additional tracking component, the procedure could be at most 1.5 hours long.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Enhetens genomförbarhet
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
proportion of navigated endoscopy procedures that were successfully completed
Tidsram: 18 months

To assess clinical feasibility of inserting intraluminal (esophagus or lung) HDR applicators using navigation technologies for tracking endoscope and applicator insertion.

This study is designed to assess the workflow when using the EM tracking technology and the accuracy of the procedure will be measured by comparison with current standard of care.

18 months
Positional accuracy
Tidsram: day 1
To compare the positional accuracy of the navigation procedure versus the current standard of care using 2D fluoroscopy using analysis of tracking data. All tracking data will be recorded for post-procedure analysis and comparison with the fluoroscopic imaging performed during current standard of care
day 1
Optimize the clinical protocol using this technology
Tidsram: 6 months
The procedure will be assessed in detail (based on time and workflow) after three patients. Participants in the review of the procedure will include surgeon, radiation oncologist, brachy-therapists and physicists. Workflow improvements will be implemented at this time.
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 januari 2017

Primärt slutförande (Faktisk)

24 april 2018

Avslutad studie (Faktisk)

24 april 2018

Studieregistreringsdatum

Först inskickad

7 februari 2017

Först inskickad som uppfyllde QC-kriterierna

9 februari 2017

Första postat (Faktisk)

14 februari 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 maj 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 maj 2018

Senast verifierad

1 maj 2018

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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