Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Monitoring of Patients Treated With Particle Therapy Using Positron-Emission-Tomography (PET): The MIRANDA Study (MIRANDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01528670
Recruitment Status : Withdrawn (Administrative barriers)
First Posted : February 8, 2012
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Juergen Debus, University Hospital Heidelberg

Tracking Information
First Submitted Date December 30, 2011
First Posted Date February 8, 2012
Last Update Posted Date May 17, 2018
Estimated Study Start Date May 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 11, 2018)
TBA [ Time Frame: TBA ]
TBA
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01528670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monitoring of Patients Treated With Particle Therapy Using Positron-Emission-Tomography (PET): The MIRANDA Study
Official Title Monitoring of Patients Treated With Particle Therapy Using Positron-Emission-Tomography (PET): The MIRANDA Study.
Brief Summary

The purpose of this clinical study is to investigate the clinical feasibility and effectiveness of off-line Positron-Emission-Tomography (PET) quality assurance for promoting the accuracy of proton and carbon ion beam therapy. One main clinical advantage of ion therapy over conventional radiation therapy is the excellent conformation of the delivered dose to the tumour volume while well sparing the surrounding healthy tissue. However, clinical exploitation of this potential to the maximum extent requires in-vivo validation of the actual treatment delivery and, in particular, of the ion beam range within the patient. Since the primary ions are completely stopped in the target volume as opposed to photon radiation, no conventional quality assurance techniques like transmission electronic portal imaging can be applied to monitor ion beam therapy. Hence, ion treatment planning currently relies on models and experimental data accurately validated in tissue-equivalent targets, but no direct verification of the actual treatment delivery and of the ion beam range within the patient is possible in standard clinical practice.

At present, PET offers the unique possibility to monitor the precision of ion irradiation in-vivo and non-invasively. The method is based on the detection of the b+-activity which is formed as a by-product of the irradiation, i.e. without administration of radio-tracers to the patient. A positive clinical impact of in-beam (i.e. during the irradiation) PET monitoring has been demonstrated for carbon ion therapy in the pilot project at GSI Darmstadt, Germany, and promising clinical data of post-radiation PET/CT imaging have been recently reported for passive proton beam delivery in USA and Japan. Therefore, a pilot clinical study is hereby proposed at the Heidelberg Ion Therapy Center in order to 1) assess the applicability of post-radiation PET imaging to scanned ion beam delivery, 2) identify the patient population which may benefit from it and 3) extract population-based information on the reliability of the beam range in different tumour locations for all the ion species clinically available at HIT.

The investigated patients are expected to benefit from this study, since in case of detected deviations between planned and actual treatment delivery a proper correction could be applied in the next irradiation fraction, assuring an overall better treatment than without any monitoring. Moreover, site-specific patient-population information on the ion range precision at HIT might enable improvement of the CT-range calibration curve as well as safe reduction of the treatment margins to promote enhanced treatment plan conformality for full clinical exploitation of the promises of ion beam therapy.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with Particle Therapy at the Heidelberg Ion Therapy (HIT) Center will be included and grouped into 8 anatomical regions: Brain, Skull base, Head-and-neck, Upper GI, Lower GI, Prostate, Pelvic region and other.
Condition Particle Therapy
Intervention Not Provided
Study Groups/Cohorts
  • Skull Base
  • Lower GI
  • Prostate
  • Pelvic Region
  • Head-and-Neck
  • Upper GI
  • Brain
  • Other
Publications * Combs SE, Bauer J, Unholtz D, Kurz C, Welzel T, Habermehl D, Haberer T, Debus J, Parodi K. Monitoring of patients treated with particle therapy using positron-emission-tomography (PET): the MIRANDA study. BMC Cancer. 2012 Apr 3;12:133. doi: 10.1186/1471-2407-12-133.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: May 11, 2018)
0
Original Estimated Enrollment
 (submitted: February 7, 2012)
240
Estimated Study Completion Date May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

  • The patient is treated at the Heidelberger Ionenstrahl Therapiezentrum (HIT) with protons or carbon ions.
  • During the radiotherapeutic treatment patient positioning is verified using validated radiological imaging such as cone beam CT, X-ray or conventional CT (Reference-Imaging as described above).
  • The patient is at least 18 years of age and is able to give informed consent.
  • The patient has been informed about the aims and the content of the study.

Exclusion Criteria

  • No informed consent to take part in the study.
  • Medical reasons that impair the patients from being in the supine position for the data acquisition time, e.g. pain.
  • Non-compliance of the patient.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01528670
Other Study ID Numbers MIRANDA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Juergen Debus, University Hospital Heidelberg
Study Sponsor University Hospital Heidelberg
Collaborators Not Provided
Investigators
Principal Investigator: Stephanie E Combs, MD University Hospital of Heidelberg
PRS Account University Hospital Heidelberg
Verification Date May 2018