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Bone Graft

ZetaFuse™ Bone Graft for Spinal Repair in Breast Cancer (ZGMBC Trial)

N/A

Recruiting

Research Sponsored by Zetagen Therapeutics, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one lytic metastatic lesion located in the vertebral body of the spine

Female patient with histologically confirmed diagnosis of primary breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

ZGMBC Trial Summary

This trial is for patients with cancer that has spread to up to 5 areas, who have a spinal instability score of 3-9, who are having the ZetaFuse bone graft implanted in their spine to help with the tumor.

Who is the study for?

This trial is for women aged 22-75 with breast cancer that has spread to the spine, causing bone defects. They must have a life expectancy of at least 12 months, no more than five metastatic lesions in three sites or less, and be able to attend follow-up visits. Exclusions include spinal cord compression, allergies to device materials, certain medication use, diabetes, active infections like AIDS or hepatitis, recent smokers or those pregnant.Check my eligibility

What is being tested?

The ZetaFuse™ Bone Graft is being tested on patients with metastatic breast cancer in the spine. It's implanted into bone defects caused by tumors in the vertebral body. The graft aims to repair these defects and improve stability for patients who meet specific criteria regarding their spinal health and number of metastases.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions to implant materials such as inflammation or infection at the site of implantation; interference with bone healing; and general surgical risks associated with percutaneous procedures.

ZGMBC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a cancerous lesion in the spine.

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I am a woman diagnosed with breast cancer through tissue analysis.

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I am between 22 and 75 years old.

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My spine is normally aligned.

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I have up to 5 cancer spread areas in no more than 3 different parts of my body.

ZGMBC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average daily dose of postoperative prescription opioid use.

Change in Back-specific Numeric Rating Scale for Pain (Back NRS) compared to baseline.

Change in SINS assessment compared to baseline.

+5 more

ZGMBC Trial Design

1Treatment groups

Experimental Treatment

Group I: Investigational Device The ZetaFuse™ Bone GraftExperimental Treatment1 Intervention

The ZetaFuse™ Bone Graft is percutaneously implanted into the bone defect created by the metastatic tumor in a spinal vertebral body. The ZetaFuse™ Bone Graft is only for implantation into the vertebral body.

0 / 5Eligibility criteria met

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Who is running the clinical trial?

Zetagen Therapeutics, IncLead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacant positions in this clinical investigation?

"Clinicaltrials.gov states this trial is actively seeking enrollees, which was first published on September 1st 2022 and the record most recently updated at a similar date."

Answered by AI

How many individuals are engaged in this clinical experiment?

"Affirmative, clinicaltrials.gov presents evidence that this medical trial is presently in search of participants since its initial publishing on September 1st 2022. Ten individuals are needed across one site and the data was most recently updated on the same day it went live."

Answered by AI

Is this investigation enrolling individuals who are fifty years or older?

"This trial's inclusion criteria mandates that applicants must be of an age between 22 and 75 years old."

Answered by AI

Is it possible for me to participate in this clinical examination?

"This medical trial is seeking 10 female patients aged between 22 and 75 that have been diagnosed with primary breast cancer. To qualify, the patient must display a minimum SINS score of 3 and a maximum of 9, while also having no more than 5 metastases located at or below three sites. Additionally, they must possess normal spinal alignment and life expectancy in excess of 12 months. Finally, all participants need to provide signed consent forms as well as agree to comply with follow-up visits throughout the study duration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ZetaFuse™ Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body

2022. "ZetaFuse™ Bone Graft in the Repair of Bone Defects From Metastatic Breast Cancer in the Spinal Vertebral Body". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05280067.