RECRUITING

Hyperpolarized 13C MRI As a Biomarker in Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a single center prospective imaging study investigating the utility of hyperpolarized 13C-pyruvate +/-13C,15N-Urea/ metabolic MR imaging. The current protocol will serve as a companion imaging biomarker study paired with standard of care (SOC) therapeutics, as well as investigational therapies that participants may be scheduled to receive outside of this protocol.

Official Title

A Phase I/II Study of Hyperpolarized 13C MRI As a Biomarker of Aggressiveness & Response to Therapy in Patients with Advanced Solid Tumors

Quick Facts

Study Start:2022-12-15

Study Completion:2026-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05599048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Presence of at least one target pelvic, abdominal, thoracic, neck or extremity lesion detected by standard staging scans that, in the judgment of study investigator, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging: 2. The participant is able and willing to comply with study procedures and provide signed and dated informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 4. Adequate renal function defined as creatinine \< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \>50 mL/min (by the Cockcroft Gault equation). 5. Participants age 18 and older. 6. Planned treatment for disease with either standard of care regimen or an investigational agent.	1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent. 2. Patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips. 3. Patients with a metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging. 4. Patients with poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160mm Hg or diastolic blood pressure greater than 100mm Hg. 5. Patients with congestive heart failure or New York Heart Association (NYHA) status \>= 2. 6. Patients who are pregnant or lactating. 7. A history of clinically significant EKG abnormalities or myocardial infarction (MI) within 6 months of study entry. 8. Any condition that, in the opinion of the Principal Investigator,

Inclusion Criteria

Exclusion Criteria

1. Presence of at least one target pelvic, abdominal, thoracic, neck or extremity lesion detected by standard staging scans that, in the judgment of study investigator, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging:
2. The participant is able and willing to comply with study procedures and provide signed and dated informed consent.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
4. Adequate renal function defined as creatinine \< 1.5 x upper limit of normal (ULN) or estimated creatinine clearance \>50 mL/min (by the Cockcroft Gault equation).
5. Participants age 18 and older.
6. Planned treatment for disease with either standard of care regimen or an investigational agent.

1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
2. Patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
3. Patients with a metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
4. Patients with poorly controlled hypertension, defined as systolic blood pressure at study entry greater than 160mm Hg or diastolic blood pressure greater than 100mm Hg.
5. Patients with congestive heart failure or New York Heart Association (NYHA) status \>= 2.
6. Patients who are pregnant or lactating.
7. A history of clinically significant EKG abnormalities or myocardial infarction (MI) within 6 months of study entry.
8. Any condition that, in the opinion of the Principal Investigator,

Contacts and Locations

Study Contact

Louise Magat

CONTACT

(415) 502-1822

Louise.Magat@ucsf.edu

Principal Investigator

Robert Bok, MD, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: Robert Bok, MD, PhD

Robert Bok, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-15

Study Completion Date2026-01-31

Study Record Updates

Study Start Date2022-12-15

Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

Biomarker

Additional Relevant MeSH Terms

Advanced Solid Tumor