AzTrials
AzTrials

Breast CancerPhase 2NCT05396118

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

A Phase 2 study testing 18F-FDG, Injection of hyperpolarized [1-13C]Pyruvate and PET/MR/MRS/MRSI scanning in people with Breast Cancer and Neuroendocrine Tumors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
18F-FDG, Injection of hyperpolarized [1-13C]Pyruvate and PET/MR/MRS/MRSI scanning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteDenmark
Study dates
18 May 2022to Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: Phase IIa Clinical Trial: Feasibility Study on Non-Invasive Simultaneous Hyperpolarized [1-13C]Pyruvate Magnetic Resonance Spectroscopy and 18F-FDG PET (hyperPET) for Metabolic Imaging in Patients With Cancer

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.

Read the detailed description

PET imaging with 18F-FDG is a well established method for non invasively assessing the intracellular glucose accumulation. 18F-FDG PET is used in many applications with diagnosing and staging of patients with cancer being one of the primary indications. Once internalized into the cell, 18F-FDG is phosphorylated to the metabolically inactive 18F-FDG-6-phosphate. Therefore it is not possible to determine what happens to the downstream glucose metabolites. In particular, it is not possible to determine the conversion into lactate, which is upregulated in many cancers. The upregulation of lactate conversion in cancers, even in presence of oxygen, is known as the Warburg effect.

Hyperpolarized [1-13C]pyruvate MRS makes is possible to circumvent this limitation. The technique makes is it possible to follow the downstream fate of the glycolysis intermediate, pyruvate, and in particular makes is is possible to non-invasively and in in real time measure the glycolytic conversion of pyruvate into lactate as a direct measure of the Warburg effect.

When using a PET/MR scanner, it is possible to simultaneous measure the glucose influx with 18F-FDG and the conversion of pyruvate into lactate with hyperpolarized [1-13C]pyruvate. In this way, the two modalities provide complementary information on the in vivo glycose metabolism.

The prospective phase 2a project will include up to 15 patients diagnosed with breast cancer, gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NEN) of all grades (G1, G2, G3)., lymphomas or sarcomas The aim is to demonstrate proof-of-concept for the feasibility of simultaneous acquisition of hyperpolarized [1-13C]pyruvate MRS and 18F-FDG PET imaging in a PET/MR scanner in cancer patients to allow for simultaneous measurements of overall tumor pyruvate-to-lactate conversion parameters on MRS and glucose influx with 18F-FDG on PET.

Included patients are injected with a standard dose of radioactive 18F-FDG. Subsequent dynamic PET acquisition is performed for up to 90 minutes after injection on an area-of-interest covering pre-specified tumor lesion(s). Regional anatomical magnetic resonance imaging (MRI) is performed, including diffusion weighted imaging (DWI) and contrast enhanced imaging (DCE). MRS/MRSI is performed following the injection(s) of hyperpolarized [1-13C]Pyruvate.

When available, resected tumor tissues samples from surgical specimens or biopsies obtained in relation to routine clinical procedures will be collected and analyses of enzymes and markers of glycolytic metabolism will be performed ex vivo and compared with the in vivo data from PET/MRS.

Being tested
18F-FDG, Injection of hyperpolarized [1-13C]Pyruvate, PET/MR/MRS/MRSI scanning
Medical subject headings
Breast Neoplasms, Neuroendocrine Tumors, Carcinoma, Neuroendocrine, Lymphoma, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FDGDrug

    Also called 18F-fluorodeoxyglucose, fluorodeoxyglucose-F-18, [18F]F-FDG

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

  • Injection of hyperpolarized [1-13C]PyruvateDrug

    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.

  • PET/MR/MRS/MRSI scanningProcedure or surgery

    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.

Study groups in NCT05396118
Study groupRoleWhat they receive
ExperimentalExperimentalInjection of 18F-FDG and injections of hyperpolarized [1-13C]Pyruvate and subsequent PET/MRI/MRS scan
Receives: Drug: 18F-FDG; Drug: Injection of hyperpolarized [1-13C]Pyruvate; Procedure: PET/MR/MRS/MRSI scanning

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

    Measured: Approximately 60 minutes after injection of 18F-FDG

  3. 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

    Measured: Up to 90 minutes after injection of 18F-FDG

  4. 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)

    Measured: Approximately 60 minutes after injection of 18F-FDG

  5. 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)

    Measured: Up to 90 minutes after injection of 18F-FDG

Secondary outcomes (1)

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

    Ex vivo measurements of enzymes, regulatory proteins and transporters involved in glucose and pyruvate/lactate transcellular transport and in glycolysis on resected matched tumor tissue samples (if available) and the correlation with the primary endpoints (whole-tumor lactate/pyruvate ratio, SUVmax, SUVmean, and Ki)

    Measured: Up to 90 minutes after injection of 18F-FDG

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2022
  2. Study start18 May 2022
  3. Primary completionAug 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05396118
Sponsor's protocol ID
AK_2021_HP
Status last verified
May 2024
First submitted
12 May 2022
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data are not publicly available due to protection of personal data according to data protection regulations and medical confidentiality.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-FDG, Injection of hyperpolarized [1-13C]Pyruvate and PET/MR/MRS/MRSI scanning in people with Breast Cancer and Neuroendocrine Tumors, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whole-tumor lactate/pyruvate ratio measured with MRS (time frame: Up to 10 minutes after injection of hyperpolarized [1-13C]Pyruvate). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05396118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in