Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGT Medical Technologies, Inc.

About this trial

The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.

Willing and able to provide informed consent and to participate in all evaluations.

Disqualifiers

Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.

Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.

Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.

Trial population

Patients who received STaRT (GammaTile) intraoperatively.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • GammaTile

    Device

    Surgically Targeted Radiation Therapy

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: GammaTile1 intervention

Trial outcomes

Primary outcomes

1

Surgical Bed-Recurrence Free Survival in Metastatic Tumor Subjects

No contrast enhancement in the area of the surgical bed

Time frame
12 months
2

Surgical Bed-Recurrence Free Survival in Meningioma Tumor Subjects

No contrast enhancement in the area of the surgical bed

Time frame
3 years
3

Overall Survival in High Grade Glioma Subjects

Median duration of survival of subjects following surgical resection of tumor

Time frame
9 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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