Hepatocellular CarcinomaEarly Phase 1NCT05111314
Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMA PET/CT for Detection of Hepatocellular Carcinoma
A Early Phase 1 study testing Gallium Ga 68 Gozetotide, Hepatic Artery Embolization and Positron Emission Tomography and Computed Tomography Scan in people with Hepatocellular Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase 0/1 study evaluates intraarterial administration of gallium Ga 68 gozetotide (68Ga-PSMA) for the detection of prostate-specific membrane antigen (PSMA) positive liver cancer by positron emission tomography (PET)/computed tomography (CT). 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?
- Gallium Ga 68 Gozetotide, Hepatic Artery Embolization and Positron Emission Tomography and Computed Tomography Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to 14 Aug 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 magnetic resonance imaging (MRI) (Liver Imaging and Reporting Data System 5 [LI-RADS 5]) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
- Already enrolled in ongoing Transform the Practice or Department of Defense 68Ga-PSMA studies
- PSMA avid HCC detected by 68Ga-PSMA PET/CT after intravenous administration of 68Ga-PSMA confirmed by a board certified nuclear radiologist
- Undergoing planned hepatic artery embolization (HAE) per standard clinical care
- 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
- 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/CT scanner
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Intraindividual Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMAPET/CT in Patients With HCC: Pilot Study
This phase 0/1 study evaluates intraarterial administration of gallium Ga 68 gozetotide (68Ga-PSMA) for the detection of prostate-specific membrane antigen (PSMA) positive liver cancer by positron emission tomography (PET)/computed tomography (CT). 68Ga-PSMA is an imaging agent used with PET/CT scans to locate PSMA positive lesions. This study evaluates intraarterial administration of this agent, compared to intravenous administration.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the tumor radiotracer uptake (first pass effect or regional advantage) of direct hepatic intraarterial (I.A.) versus systemic intravenous (I.V.) 68Ga-PSMA in patients with PSMA+ hepatocellular carcinoma (HCC) by PET/CT.
OUTLINE:
Patients undergoing clinically indicated hepatic artery embolization will receive 68Ga-PSMA intraarterially (IA) over 5 minutes. After 60-90 minutes, patients undergo PET/CT scan over 1 hour.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Gallium Ga 68 Gozetotide, Hepatic Artery Embolization, Positron Emission Tomography and Computed Tomography Scan
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium Ga 68 GozetotideRadiation
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 IA
Hepatic Artery EmbolizationProcedure or surgery
Undergo hepatic artery embolization
Positron Emission Tomography and Computed Tomography ScanProcedure or surgery
Also called PET-CT Scan, PET/CT SCAN, Positron Emission Tomography/Computed Tomography
Undergo PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (embolization, 68Ga-PSMA, PET/CT) | Experimental | Patients undergoing clinically indicated hepatic artery embolization will receive 68Ga-PSMA intraarterially (IA) over 5 minutes. After 60-90 minutes, patients undergo PET/CT scan over 1 hour. Receives: Radiation: Gallium Ga 68 Gozetotide; Procedure: Hepatic Artery Embolization; Procedure: Positron Emission Tomography and Computed Tomography Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)
Intraindividual intralesional difference in maximum standardized uptake value (SUVmax) will be evaluated as fold change and absolute difference for a given lesion between intra-arterially (I.A.) and intravenous (I.V.) prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Qualitative evaluation assesses the intensity of PSMA uptake in hepatic lesions, graded as follows: grade 1: uptake < normal liver; grade 2: uptake = normal liver; grade 3: uptake > normal liver; grade 4: uptake > spleen or kidneys. Semi-quantitative analysis is undertaken by calculating intraindividual difference in SUVmax for each lesion between I.A. and I.V. PSMA PET followed by a two-sided one sample t-test. Maximum and mean standardized uptake value (SUVmax, SUVmean, SUVmin) of the lesion(s), and SUVmax of the background liver are noted.
Measured: Up to 2 years
Secondary outcomes (3)
Intraindividual intralesional differences in tumor to background (TBR) of SUVmax
For each lesion, tumor-to-liver background ratio (TBR) of SUVmax will be calculated and the intraindividual intralesional difference in TBR of SUVmax will be compared on a lesion basis between I.A. and I.V. PSMA PET.
Measured: Up to 2 years
Difference in PSMA uptake measured by SUVmax (fold change, absolute difference) in the kidneys, spleen and salivary glands between I.A. and I.V. PSMA PET.
SUVmax will be measured for the kidneys, spleen and salivary glands and the difference in PSMA uptake measured by SUVmax (fold change, absolute difference) in the kidneys, spleen and salivary glands will be compared between I.A. and I.V. PSMA PET
Measured: Up to 2 years
Incidence of adverse events
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start11 Feb 2022
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Why it stopped: PI requested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott M. Thompson, Mayo Clinic
- Investigators
- Scott M Thompson, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111314
- Sponsor's protocol ID
- 21-004930
- Other IDs
- NCI-2021-11290
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraindividual Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMAPET/CT in Patients With HCC: Pilot Study
- ClinicalTrials.gov ID
- NCT05111314
- Acronym / sponsor ID
- 21-004930
- Conditions
- Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI requested
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 0/1 study evaluates intraarterial administration of gallium Ga 68 gozetotide (68Ga-PSMA) for the detection of prostate-specific membrane antigen (PSMA) positive liver cancer by positron emission tomography (PET)/computed tomography (CT). 68Ga-PSMA is an imaging agent used with PET/CT scans to locate PSMA positive lesions. This study evaluates intraarterial administration of this agent, compared to intravenous administration.
Detailed description
PRIMARY OBJECTIVE:
- To determine the tumor radiotracer uptake (first pass effect or regional advantage) of direct hepatic intraarterial (I.A.) versus systemic intravenous (I.V.) 68Ga-PSMA in patients with PSMA+ hepatocellular carcinoma (HCC) by PET/CT.
OUTLINE:
Patients undergoing clinically indicated hepatic artery embolization will receive 68Ga-PSMA intraarterially (IA) over 5 minutes. After 60-90 minutes, patients undergo PET/CT scan over 1 hour.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (embolization, 68Ga-PSMA, PET/CT) | Experimental | Radiation: Gallium Ga 68 Gozetotide, Procedure: Hepatic Artery Embolization, Procedure: Positron Emission Tomography and Computed Tomography ScanPatients undergoing clinically indicated hepatic artery embolization will receive 68Ga-PSMA intraarterially (IA) over 5 minutes. After 60-90 minutes, patients undergo PET/CT scan over 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with either an imaging diagnosis of HCC by CT or magnetic resonance imaging (MRI) (Liver Imaging and Reporting Data System 5 [LI-RADS 5]) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
- Already enrolled in ongoing Transform the Practice or Department of Defense 68Ga-PSMA studies
- PSMA avid HCC detected by 68Ga-PSMA PET/CT after intravenous administration of 68Ga-PSMA confirmed by a board certified nuclear radiologist
- Undergoing planned hepatic artery embolization (HAE) per standard clinical care
- Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent
Key exclusion criteria (3 listed)
- Subjects requiring emergent surgery for a ruptured/bleeding HCC
- 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/CT scanner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium Ga 68 GozetotideAlso: (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-CCGiven IA | Radiation | Diagnostic (embolization, 68Ga-PSMA, PET/CT) |
| Hepatic Artery EmbolizationUndergo hepatic artery embolization | Procedure or surgery | Diagnostic (embolization, 68Ga-PSMA, PET/CT) |
| Positron Emission Tomography and Computed Tomography ScanAlso: PET-CT Scan, PET/CT SCAN, Positron Emission Tomography/Computed TomographyUndergo PET/CT scan | Procedure or surgery | Diagnostic (embolization, 68Ga-PSMA, PET/CT) |
Primary outcome
Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)
Time frame: Up to 2 years
Intraindividual intralesional difference in maximum standardized uptake value (SUVmax) will be evaluated as fold change and absolute difference for a given lesion between intra-arterially (I.A.) and intravenous (I.V.) prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Qualitative evaluation assesses the intensity of PSMA uptake in hepatic lesions, graded as follows: grade 1: uptake < normal liver; grade 2: uptake = normal liver; grade 3: uptake > normal liver; grade 4: uptake > spleen or kidneys. Semi-quantitative analysis is undertaken by calculating intraindividual difference in SUVmax for each lesion between I.A. and I.V. PSMA PET followed by a two-sided one sample t-test. Maximum and mean standardized uptake value (SUVmax, SUVmean, SUVmin) of the lesion(s), and SUVmax of the background liver are noted.
3 secondary outcomes
Intraindividual intralesional differences in tumor to background (TBR) of SUVmax
Time frame: Up to 2 years
Difference in PSMA uptake measured by SUVmax (fold change, absolute difference) in the kidneys, spleen and salivary glands between I.A. and I.V. PSMA PET.
Time frame: Up to 2 years
Incidence of adverse events
Time frame: Up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott M Thompson principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gallium Ga 68 Gozetotide, Hepatic Artery Embolization and Positron Emission Tomography and Computed Tomography Scan 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 3 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: withdrawn, as of the sponsor's last update on 7 Nov 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Intraindividual intralesional difference in maximum standardized uptake value (SUVmax) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.