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Hepatocellular CarcinomaEarly Phase 1NCT04310540

PSMA PET/MRI or PSMA PET/CT for Evaluation of Liver Cancer

A Early Phase 1 study testing Biopsy, Computed Tomography and Gallium Ga 68 Gozetotide in people with Hepatocellular Carcinoma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial evaluates whether 68Ga-PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer. MRI stands for magnetic resonance imaging, a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues and structures within the body. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Biopsy, Computed Tomography and Gallium Ga 68 Gozetotide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
5 Jun 2020to 2 Nov 2023
Phase
Early Phase 1
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

  • Patients with either an imaging diagnosis of HCC by CT or MRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
  • Subjects who may undergo hepatic surgical resection, liver transplant, hepatic locoregional therapy (ablation, embolization, etc.) or systemic therapy
  • No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm)
  • For the systemic therapy arm, patients who have had unequivocal progression after prior locoregional therapy (LRT) and/or those undergoing de novo systemic therapy in view of advanced HCC at diagnosis
  • Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent

Who cannot join

  • Subjects requiring emergent surgery for a ruptured/bleeding HCC
  • Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent (relevant to PET/MRI)
  • Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan
  • Subjects with higher than the weight/size limitations of PET/MRI or PET/CT scanner
  • Subjects with contraindication to MRI (relevant to PET/MRI):
  • Subjects who have a heart pacemaker
Show all 12Show fewer
  • Subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain
  • Subjects who have implanted devices with magnets
  • Subjects who have other implanted electronic devices
  • Subjects who have deep brain stimulator
  • Subjects who have vagal nerve stimulator
  • Subjects with cochlear (ear) or auditory implants

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Development and Validation of Innovative Hybrid Molecular Imaging, 68Ga-PSMA-Dual Contrast PET/MRI and 68Ga-PSMA PET/CT, to Transform the Care of Patients with Hepatocellular Carcinoma

This clinical trial evaluates whether 68Ga-PSMA PET/MRI or PET/CT can improve upon the diagnosis and management of liver cancer. MRI stands for magnetic resonance imaging, a scan that uses magnetic and radio waves to produce detailed structural information of the organs, tissues and structures within the body. PET stands for positron emission tomography, an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. In patients that have been diagnosed with liver cancer, a protein called prostate specific membrane antigen (PSMA) appears in large amounts on the surface of the cancerous cells. The radioactive chemical compound (68Ga-PSMA) has been designed to circulate through the body and attach itself to the PSMA protein on liver cancer cells. 68Ga-PSMA PET/MRI or PET/CT may be better in diagnosing and managing liver cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate diagnostic performance of gallium Ga 68 gozetotide (68Ga-PSMA-dual contrast [Gadavist and gadoxetate]) positron emission tomography (PET)/magnetic resonance imaging (MRI) OR PET/computed tomography (CT) for hepatocellular carcinoma (HCC) using surgical histopathology (either resection, transplant or biopsy specimens) or Liver Imaging and Reporting Data System (LI-RADS) categorization as gold standard.

II. To evaluate treatment response after locoregional therapy or systemic therapy in HCC using 68Ga-PSMA uptake at PET (qualitative \& semi-quantitative measures) and to compare it with standard CT/MRI morphologic and post-contrast enhancement based response criteria (modified Response Evaluation Criteria in Solid Tumors [mRECIST] and LI-RADS-treatment response [LR-TR] algorithm).

III. To determine association between PSMA uptake in HCCs at PET with tissue prostate specific membrane antigen (PSMA) expression using immunohistochemistry or serum/plasma PSMA expression using enzyme-linked immunosorbent assay (ELISA).

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV), and undergo PET/MRI over 60 minutes or PET/CT over 30 minutes at baseline and 12 weeks after completion of hepatic locoregional therapy or 8-12 weeks after completion of systemic therapy. Patients undergoing hepatic locoregional therapy may also undergo a liver biopsy.

Being tested
Biopsy, Computed Tomography, Gallium Ga 68 Gozetotide, Magnetic Resonance Imaging, Positron Emission Tomography
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • BiopsyProcedure or surgery

    Also called BIOPSY_TYPE, Bx

    Undergo biopsy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Gallium Ga 68 GozetotideDrug

    Also called (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC, (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC, (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC, (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

Study groups in NCT04310540
Study groupRoleWhat they receive
Diagnostic (gallium Ga 68 gozetotide PET/MRI, PET/CT, biopsy)ExperimentalPatients receive gallium Ga 68 gozetotide IV, and undergo PET/MRI over 60 minutes or PET/CT over 30 minutes at baseline and 12 weeks after completion of hepatic locoregional therapy or 8-12 weeks after completion of systemic therapy. Patients undergoing hepatic locoregional therapy may also undergo a liver biopsy.
Receives: Procedure: Biopsy; Procedure: Computed Tomography; Drug: Gallium Ga 68 Gozetotide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

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

  1. Diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) positron emission tomography/magnetic resonance imaging (PET/MRI), or 68Ga-PSMA positron emission tomography/computed tomography (PET/CT)

    Using surgical histopathology (either resection or transplant specimens) or Liver Imaging and Reporting Data System (LI-RADS[R]) categorization as gold standard.

    Measured: At 3 months after completion of hepatic locoregional therapy or systemic therapy

  2. Treatment response after locoregional therapy in hepatocellular carcinoma (HCC)

    Using 68Ga-PSMA uptake at PET (qualitative \& semi-quantitative measures) compared with standard CT/MRI morphologic and post-contrast enhancement based response criteria (modified Response Evaluation Criteria in Solid Tumors and LI-RADS-treatment response [LR-TR] algorithm).

    Measured: Completion of locoregional therapy (up to 3 months)

  3. Association between prostate specific membrane antigen (PSMA) uptake in hepatocellular carcinoma at PET with tissue PSMA expression

    Assessed using immunohistochemistry, serum/plasma PSMA expression using enzyme-linked immunosorbent assay or serum HCC tumor markers.

    Measured: Up to 3 years

Timeline

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

  1. First posted17 Mar 2020
  2. Study start5 Jun 2020
  3. Primary completion2 Nov 2023
  4. Study completion2 Nov 2023

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
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04310540
Sponsor's protocol ID
19-012563
Other IDs
NCI-2021-02760
Status last verified
Sep 2024
First submitted
13 Mar 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biopsy, Computed Tomography and Gallium Ga 68 Gozetotide in people with Hepatocellular Carcinoma, run by Mayo Clinic at 1 site in United States.

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 5 inclusion and 12 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: finished, as of the sponsor's last update on 19 Sep 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 United States. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) positron emission tomography/magnetic resonance imaging (PET/MRI), or 68Ga-PSMA positron emission tomography/computed tomography (PET/CT) (time frame: At 3 months after completion of hepatic locoregional therapy or systemic therapy). The study lists 3 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 NCT04310540.

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 19 Sep 2024.

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