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Clinical Trials/NCT01757717
NCT01757717
Completed
Not Applicable

A Pilot Study of Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis

Memorial Sloan Kettering Cancer Center1 site in 1 country3 target enrollmentStarted: January 2013Last updated:
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ConditionsMetastatic or Recurrent Lesions in the SpineMetastatic or Recurrent Lesions in the Pelvis

Overview

Phase
Not Applicable
Status
Completed
Enrollment
3
Locations
1
Primary Endpoint
Maximum Radiation Dose
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this study is to see if using a form of imaging during surgery helps the doctors to guide the placement of radiation catheters more accurately.

This method, called "image-guided surgical navigation" may allow the doctors to deliver radiation to the tumor that the patient needs and decrease the amount of radiation delivered to the nearby areas.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients must have histologic proof of a malignancy suitable for radiation therapy.
  • •Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration.
  • •If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible.
  • •If the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals
  • •\[Rades 2005, Nieder 2005, Sahgal 2012\]
  • •Age ≥ 18 years old

Exclusion Criteria

  • •Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria.
  • •Patients with kyphoplasty cement or hardware that would preclude effective catheter placement.
  • •Patients with paraspinal extension of disease with visceral involvement.
  • •Abnormal complete blood count. Any of the following:
  • •Platelet count \< 75,000/ml
  • •Hb level \< 9gm/dl
  • •WBC \< 3.5/ml
  • •Abnormal coagulation profile: INR \> 2.5 and/or PTT \> 80
  • •Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.
  • •Contraindications to general anesthesia

Outcomes

Primary Outcomes

Maximum Radiation Dose

Time Frame: 1 year

Verify feasibility of HDF treatment of spinal and/or pelvic lesions using catheters placed under image-guided navigational techniques, to provide improved dosimetric coverage of lesions such that Cord/Cauda Dmax of \<8 Gy

Secondary Outcomes

  • Number of Grade 3 of Higher Toxicities(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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