Simultaneous Hyperpolarized [1-13C]Pyruvate and 18F-FDG PET/MRS in Cancer Patients

NCT05396118 | Enrolling By Invitation Phase 2

• 1 other identifier: AK_2021_HP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective phase 2a clinical trial to demonstrate proof-of-concept for simultaneous hyperpolarized \[1-13C\]pyruvate and 18F-FDG for positron emission tomography (PET) and MRS (magnetic resonance spectroscopy) in a PET/MR scanner in patients with cancer.

Conditions

Breast Cancer; Neuroendocrine Tumors; Neuroendocrine Carcinoma; Neuroendocrine Carcinoma Metastatic; Lymphoma; Sarcoma

Outcome Measures

Primary Outcomes (5)

• Whole-tumor lactate/pyruvate ratio measured with MRS

  Whole-tumor lactate/pyruvate ratio measured with MRS in regions-of-interest covering the tumor lesion(s) following injection of hyperpolarized \[1-13C\]Pyruvate

  Up to 10 minutes after injection of hyperpolarized [1-13C]Pyruvate

• Whole-tumor glucose uptake measured with PET (static)

  Whole-tumor standardized uptake values (SUV): SUVmean and SUVmax measured with PET in regions-of-interest covering the tumor lesion(s) approximately 60 minutes after injection of 18F-FDG

  Approximately 60 minutes after injection of 18F-FDG

• Whole-tumor glucose uptake measured with PET (dynamic)

  Whole-tumor glucose influx rate constant (Ki) derived from dynamic PET in regions-of-interest covering the tumor lesion(s) following injection of 18F-FDG

  Up to 90 minutes after injection of 18F-FDG

• Correlation between whole-tumor lactate/pyruvate ratio measured with MRS and tumor glucose uptake measured with PET (static)

  Correlation between whole-tumor lactate/pyruvate ratio measured with MRS and whole-tumor SUVmean and SUVmax measured with PET in regions-of-interest covering the tumor lesion(s)

  Approximately 60 minutes after injection of 18F-FDG

• Correlation between whole-tumor lactate/pyruvate ratio measured with MRS and tumor glucose uptake measured with PET (dynamic)

  Correlation between whole-tumor lactate/pyruvate ratio measured with MRS and whole-tumor Ki measured with PET in regions-of-interest covering the tumor lesion(s)

  Up to 90 minutes after injection of 18F-FDG

Secondary Outcomes (1)

• Correlation between measurements of in vivo glycolytic markers based on PET/MRS and enzymes involved in glycolytic metabolism based on ex vivo analyses

  Up to 90 minutes after injection of 18F-FDG

Other Outcomes (5)

• Tertiary (exploratory) Outcome Measure: Spatially mapped tumor lactate/pyruvate ratios measured with MRS

  Up to 10 minutes after injection of hyperpolarized [1-13C]Pyruvate

• Tertiary (exploratory) Outcome Measure: Spatially mapped tumor glucose uptakes measured with PET (static)

  Approximately 60 minutes after injection of 18F-FDG

• Tertiary (exploratory) Outcome Measure: Spatially mapped tumor glucose uptakes measured with PET (dynamic)

  Up to 90 minutes after injection of 18F-FDG

Study Arms (1)

Experimental

EXPERIMENTAL

Injection of 18F-FDG and injections of hyperpolarized \[1-13C\]Pyruvate and subsequent PET/MRI/MRS scan

Drug: 18F-FDG; Drug: Injection of hyperpolarized [1-13C]Pyruvate; Procedure: PET/MR/MRS/MRSI scanning

Interventions

18F-FDG DRUG

Injection of 4 MBq/kg of 18F-FDG followed by dynamic positron emission tomography (PET) imaging

Also known as: 18F-fluorodeoxyglucose, fluorodeoxyglucose-F-18, [18F]F-FDG

Experimental

Injection of hyperpolarized [1-13C]Pyruvate DRUG

Injection of one bolus of 0.43 ml/kg of approximately 250 mM hyperpolarized \[1-13C\]Pyruvate followed by magnetic resonance spectroscopy (MRS) / magnetic resonance spectroscopy imaging (MRSI). After a 5-30 min pause, injection of a second bolus of 0.43 ml/kg of approximately 250 mM hyperpolarized \[1-13C\]Pyruvate followed by MRS / MRSI.

Experimental

PET/MR/MRS/MRSI scanning PROCEDURE

Regional dynamic PET acquisition for up to 90 minutes following 18F-FDG injection is performed focused on a region-of-interest (ROI). Anatomical magnetic resonance imaging (MRI) is performed in the ROI, including diffusion weighted imaging (DWI) and contrast enhanced imaging (DCE). MRS/MRSI is performed following the injections of hyperpolarized \[1-13C\]Pyruvate.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with breast cancer, gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NEN) grades G1, G2 or G3, lymphoma or sarcoma
• Measurable solid tumor of at least 1.5 cm
• Capable of understanding the patient information in Danish and giving full informed consent

You may not qualify if:

• Pregnancy
• Breast-feeding
• Weighs above 140 kg and/or with abdominal circumference exceeding the gantry of the PET/MR coil (120 cm)
• History of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FDG or pyruvate
• Patients who are unable to lie in the MR scanner for up to 90 minutes
• Pace-maker
• Metallic implantations within the past 6 weeks
• Non-MR compatible implants
• Claustrophobia
• Participants who have not fasted for a minimum of 4 hours prior to the planned scan time

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms; Neuroendocrine Tumors; Carcinoma, Neuroendocrine; Lymphoma; Sarcoma

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Mathias Loft, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• Andreas Kjaer, MD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 31, 2022
• Study Start: May 18, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)