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Central Nervous System LesionNCT03088579

Intraoperative Brachytherapy for Central Nervous System Lesions: A Validation Study of a Radioactive Seed Loading Device

An observational study of Central Nervous System Lesion, run by St. Joseph's Hospital and Medical Center, Phoenix at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The researchers recognized the possible clinical usefulness of a shielded device or jig to help increase the accuracy but decrease the time of loading the seeds into the biocompatible material used intra-operatively. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Nervous System Lesion
What is being tested?
GammaTile seed loader
Type of treatment
Medical device
How many people
120 participants
Where
2 sitesUnited States
Study dates
2 Apr 2013to 11 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults of either gender having a central nervous system lesion (high grade primary brain tumor and electing intra-operative brachytherapy. Participants will be patients of Barrow Brain and Spine neurosurgery group located in Phoenix AZ.

Who may be able to join

  • Planned for resection of aggressive primary or metastatic brain tumor and appropriate for adjuvant radiotherapy.
  • Zubrod Performance Score of 0-2.
  • 18 years of age or older.
  • Pre-operative stereotactic CT or MRI.
  • Life expectancy >26 weeks.
  • History and physical for all patients and detailed neurological exams.
  • Signed study-specific informed consent form prior to study entry.

Who cannot join

  • Negative biopsy if presumed diagnosis on imaging.
  • External beam therapy is allowed if the implant is being used instead of a boost or cone down treatment.
  • Life expectancy < 26 weeks.
  • Inability to undergo post-operative CT for implant assessment, or postoperative follow-up imaging.
  • Major medical or psychiatric illness, which, in the investigator's opinion, would prevent completion of treatment and/or interfere with follow-up.
  • Inability or refusal to provide informed consent.
  • Prior radiation therapy in excess of 100Gy to site of implant.
  • Patients in which there is no cranium in place (for example, bone flap removed for infection).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Barrow Brain and Spine

    Phoenix, Arizona, 85013

  • Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

Other trials in United States

About this study

The researchers recognized the possible clinical usefulness of a shielded device or jig to help increase the accuracy but decrease the time of loading the seeds into the biocompatible material used intra-operatively. Therefore, the researchers created a prototype of a device called the GammaTile (GT) loader (design patent pending). The reusable device will be made of surgical quality stainless steel of sufficient thickness (greater than 10 half-value layers (HVL) to provide significant staff and user shielding as well as allowing it to be sterilized. It is utilized intraoperatively but off of the operative field and has no direct patient contact. Currently two sizes are planned. The first will accommodate a 2 inch x 2 inch collagen square and the second will accommodate a 1 inch x 1 inch collagen square. These are the most commonly used sizes of lyophilized collagen used in the Barrow Neurosurgical Institute (BNI) operating rooms (OR).

Read the detailed description

This is a 100 patient observational-design study for the purpose of testing the seed loader device as a method of arranging and securing the seeds in a carrier in a set pattern for the convenient use of the neurosurgeon against the backdrop of a hodgepodge of currently available techniques (seed in suture, seed in mesh, loose seeds), all of which currently need to be secondarily secured with some additional, not currently standardized material, in a cumbersome, time-consuming, and not assuredly accurate manner. An additional primary objective will be an assessment of the loader device as a radiation protection tool for the user and staff during seed placement in the carrier and prior to intracranial carrier placement. Secondary objectives will be conformality of pre- and post-implant dosimetry (expected vs achieved) and post implant stability (seed shift) over time as judged on a routine follow up MRI. An additional proposed endpoint is an economic (cost) comparison to other modalities.

Eligible patients are those deemed appropriate for and scheduled to undergo adjuvant brachytherapy of the central nervous system as determined by the radiation oncologist and neurosurgeon. Potential candidates will have a lesion(s) that may be newly diagnosed or recurrent, in need of gross total or near gross total resection, and such that in the opinion of the operating surgeon it would be both amenable to and in need of the proposed treatment. Informed consent will be obtained. Radiation oncologist and neurosurgeon will determine appropriateness of the proposed procedure and the radiation oncologist and neurosurgeon will determine the volume and configuration of the area to be implanted.

A carrier using currently available material (lyophilized bovine-derived collagen, Duraform or similar) stocked in the BNI OR. The isotope (seeds) are also already approved for use anywhere in the body, are in use and on the hospital's radioactive materials license (RML). Patients will have pre- and post-operative computerized tomography (CT) or magnetic resonance imaging (MRI) as routine care, and post-operative CT's as per routine implant case dosimetry. All applicable radiation safety procedures will continue to be followed. The sterilizable loader(s) will be provided as a non-charge-item, and are anticipated to be classified as a "Class 1" device by the FDA as they are not implanted and have no direct patient contact.

Being tested
GammaTile seed loader
Keywords
radiation shielding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GammaTile seed loaderDevice

    Patients are chosen based on symptomatic tumor/radiographic finding of a surgically accessible mass. Surgery will be done in usual fashion. A cavity will be left where the tumor was. Size of operative bed will be measured using a surgical dissector and standard operating room ruler. A sheet of surgical fabric may be used to estimate size of cavity. If pathology is positive the study treatment will continue. If not, patient will not be on trial. If patient is eligible, radiation oncologist will form custom implants using a seed(s) of Cesium-131, with other biocompatible materials used to achieve maximum dosimetric conformality. Surgeon will place constructs into cavity until the operative bed is fully addressed. Implant is not expected to migrate. Surgicel, bioglue or similar material may be used to secure seeds. Wound will be closed in standard fashion. The last 10 patients will be asked to participate in an effort to gauge costs related to radiation portion of treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. User's Experience

    Analyze users' (radiation oncologists and neurosurgeons) experience with the loader methodology by utilizing a standardized questionnaire recording 1) time added to case, 2) the size and size range of implants utilized, 3) conformality to operative bed, and 4) ease of use. Both perceptual (subjective) and numerical (objective) data will be obtained.

    Measured: Immediately post-operatively

  2. Shielding

    Evaluate shielding (radiation protection ability) of shielded loader through mRm measurements while seeds are in loader prior to implantation: surface of loader (mRm/hour), at 1 meter (mRm/hour), and at 3 meter (mRm/hour).

    Measured: Immediately post-operatively

Secondary outcomes (7)

  1. Post-Implant Dosimetric Analysis

    Using Advisory Committee on the Medical Uses of Isotopes (ACMUI) guidelines, analyze the post-implant dosimetry and compare with the pre-plan dosimetry (expected vs achieved dosimetry) both of which are standard procedures for brachytherapy.

    Measured: Post-operative Day 1

  2. Seed Migration

    Presence or absence of source (seed) migration on subsequent scans ordered for routine follow-up.

    Measured: Post-operative Day 1

  3. Economic Impact

    For all study patients obtain sufficiently detailed, global costs for treatment to be able to analyze the overall cost of this modality compared to existing literature data for other forms of adjuvant therapies where available.

    Measured: Post-Operative Day 1, at follow-up per routine care (up to 5 years)

  4. Progression Free Survival (PFS)

    The length of time during and after treatment that the participant lives with the disease but it does not get worse.

    Measured: Pre-Operative and at follow-up per routine care (up to 5 year)

  5. Overall Survival (OS)

    The length of time from when consent is signed that participants are still alive.

    Measured: Pre-Operative and at follow-up per routine care (up to 5 year)

  6. Zubrod Performance Scale

    Participants ability to carry out activities of daily living will be scored per the following scale:

    0 Fully active, able to carry on all predisease activities without restriction (Karnofsky 90-100);

    1. Restricted in physically strenuous activity but ambulatory and able to carry work of a light or sedentary nature. For example, light housework, office work (Karnofsky 70-80);
    2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours (Karnofsky 50-60);
    3. Capable of only limited self-care, confined to bed or chair 50% or more of waking hours (Karnofsky 30-40);
    4. Completely disabled. Cannot carry on self-care. Totally confined to bed or (Karnofsky 10-20);
    5. Death (Karnofsky 0).

    Measured: Pre-Operative, Post-Operative Day 1, at follow-up per routine care (up to 5 years)

  7. Neurologic Function Status Scale

    Participants' neurologic status will be scored per the following scale:

    0 No neurologic symptoms - fully active at home/work without assistance;

    1. Minor neurologic symptoms - fully active at home/work without assistance;
    2. Moderate neurologic symptoms - fully active at home/work but requires assistance;
    3. Moderate neurologic symptoms - less than fully active at home/work and requires assistance;
    4. Severe neurologic symptoms - totally inactive requiring complete assistance at home or in institution--unable to work.

    Measured: Pre-Operative, Post-Operative Day 1, at follow-up per routine care (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2017
  2. Study start2 Apr 2013
  3. Primary completion28 Feb 2018
  4. Study completion11 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03088579
Sponsor's protocol ID
13RT022
Status last verified
Mar 2023
First submitted
1 Mar 2017
Last updated
12 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pinnaduwage DS, Srivastava SP, Yan X, Jani S, Brachman DG, Sorensen SP. Dosimetric Impacts of Source Migration, Radioisotope Type, and Decay with Permanent Implantable Collagen Tile Brachytherapy for Brain Tumors. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221106852. doi: 10.1177/15330338221106852.

    PubMed 35712977

Questions about this trial

What is this clinical trial studying?

An observational study of Central Nervous System Lesion, run by St. Joseph's Hospital and Medical Center, Phoenix at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

User's Experience (time frame: Immediately post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03088579, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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