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Chemotherapy

Hyperpolarized Pyruvate (13C) Injection for Breast Cancer (LABC Trial)

Phase 1

Waitlist Available

Led By Charles Cunningham, PhD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

LABC Trial Summary

This trial is studying a new MRI technique to see if it can detect early changes in breast cancer tumors during neoadjuvant chemotherapy.

Eligible Conditions

Breast Cancer

LABC 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

Time resolved, 3D 13C pyruvate MR images using MRI

Secondary outcome measures

Accuracy of time resolved, 3D 13C pyruvate MR imaging using visual analysis of MRI images

Lactate Correlation using visual analysis of MRI Images

Visual differentiation between tumour necrosis versus viable tumour

LABC Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Hyperpolarized Pyruvate (13C) InjectionActive Control2 Interventions

The Participants in the active comparator arm will be injected with study drug Hyperpolarized Pyruvate (13C) Injection at a dose of 0.43/ml/kg. After the injection research, MRI will be done and images evaluated.

Group II: Coil TestingPlacebo Group2 Interventions

Participants will receive an MRI with a 1 cm diameter plastic ball that contains 13C-urea that acts as test object. It provides a signal that is used to ensure that the MRI system is functioning properly.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,622 Total Patients Enrolled

29 Trials studying Breast Cancer

16,136 Patients Enrolled for Breast Cancer

Charles Cunningham, PhDPrincipal InvestigatorSunnybrook Research Institute

5 Previous Clinical Trials

271 Total Patients Enrolled

Frequently Asked Questions

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

How secure is the administration of Hyperpolarized Pyruvate (13C) Injection for those receiving treatment?

"Limited efficacy and safety data results in a score of 1 being assigned to Hyperpolarized Pyruvate (13C) Injection on our team's scale, considering it is still in Phase 1."

Answered by AI

May I join this medical research initiative?

"People diagnosed with breast cancer and aged between 18 to 80 years of age are eligible for this research. Currently, the trial is looking to recruit 13 participants."

Answered by AI

How many participants are being accepted into this research trial?

"Affirmative; the study's information on clinicaltrials.gov reveals that it is actively searching for participants. Inception occurred November 21st 2017 and was recently updated May 4th 2022, with a need of 13 enrollees from one medical facility."

Answered by AI

Are applications currently being accepted for this research trial?

"Affirmative, clinicaltrials.gov data confirms that this research is presently recruiting participants. The trial was originally uploaded on November 21st 2017 and its details were last modified on May 4th 2022. Presently, 13 individuals are being sought from a single medical site."

Answered by AI

Are geriatric individuals being admitted to this research project?

"This trial is only available for those aged 18 to 80. For minors, there are 74 clinical trials and 2505 opportunities for senior citizens aged 65 or above."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

2017. "Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03121989.