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Radioactive Chemical Compound
Ga 68 PSMA PET/CT Imaging for Liver Cancer
Phase 2
Recruiting
Led By Nguyen H Tran
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from study registration to disease progression per recist 1.1 and per psma pet/ct, assessed up to 3 years
Awards & highlights
Study Summary
This trial is testing whether a new imaging technique can improve the diagnosis and management of liver cancer. The new technique uses a radioactive chemical compound that attaches to a protein found on liver cancer cells. This allows doctors to see where the cancer cells are located.
Who is the study for?
This trial is for adults over 18 with advanced liver cancer that can't be removed by surgery or treated with curative intent. They must have a type of tumor that can be measured and be eligible for specific front-line therapy. Pregnant or breastfeeding individuals, or those too large for the PET/CT scanner are excluded.Check my eligibility
What is being tested?
The trial is testing if a new imaging technique using a radioactive compound called 68Ga-PSMA improves diagnosis and management of advanced liver cancer. It involves PET scans to detect tumors after the compound binds to proteins on cancer cells.See study design
What are the potential side effects?
Potential side effects may include reactions to the radioactive tracer used in imaging, such as mild allergic reactions, discomfort at injection site, or exposure to radiation which is within safe limits but could carry long-term risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer cannot be treated with surgery, transplant, or targeted therapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from study registration to disease progression per recist 1.1 and per psma pet/ct, assessed up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from study registration to disease progression per recist 1.1 and per psma pet/ct, assessed up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Time to progression
Time to treatment response
Side effects data
From 2023 Phase 2 trial • 257 Patients • NCT0133303379%
Nausea
64%
Platelet count decreased
46%
Vomiting
46%
Neutrophil count decreased
41%
Paresthesia
41%
Diarrhea
38%
Lymphocyte count decreased
28%
Dysphagia
26%
Dyspnea
23%
Fatigue
21%
White blood cell decreased
18%
Anemia
15%
Anorexia
15%
Headache
13%
Peripheral motor neuropathy
13%
Dehydration
10%
Laryngopharyngeal dysesthesia
10%
Flu like symptoms
10%
Fever
10%
Hyponatremia
10%
Myalgia
8%
Insomnia
8%
Esophageal pain
8%
Esophagitis
8%
Chills
8%
Weight loss
8%
Hyperglycemia
8%
Hypocalcemia
8%
Arthralgia
8%
Hypotension
5%
Hypoalbuminemia
5%
Sinus tachycardia
5%
Pain
5%
Bloating
5%
Constipation
5%
Hypokalemia
5%
Peripheral sensory neuropathy
5%
Aspiration
5%
Alopecia
5%
Skin and subcut tissue disord - Oth spec
5%
Febrile neutropenia
3%
Hypoxia
3%
Soft tissue infection
3%
Hypophosphatemia
3%
Depression
3%
Pharyngolaryngeal pain
3%
Dysgeusia
3%
Gastroparesis
3%
Pain in extremity
3%
Edema limbs
3%
Stomach pain
3%
Cardiac arrest
3%
Thrombotic thrombocytopenic purpura
3%
Esophageal hemorrhage
3%
Esophageal obstruction
3%
Lung infection
3%
Sepsis
3%
Tooth infection
3%
Alkaline phosphatase increased
3%
Back pain
3%
Atelectasis
3%
Cough
3%
Epistaxis
3%
Hiccups
3%
Hoarseness
3%
Pleural effusion
3%
Pleuritic pain
3%
Rash maculo-papular
3%
Hypertension
3%
Phlebitis
3%
Superficial thrombophlebitis
3%
Vascular disorders - Other, specify
3%
Thromboembolic event
3%
Blood and lymph sys disorders - Oth Spec
3%
Palpitations
3%
Sinus bradycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
FOLFOX Non-Responder
CP Responder
FOLFOX Responder
CP Non-Responder
CP No Cross-over
FOLFOX No Cross-over
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (68GA PSMA PET/CT)Experimental Treatment3 Interventions
Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium Ga 68 Gozetotide
2020
Completed Phase 3
~1750
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,986 Total Patients Enrolled
4 Trials studying Liver Cancer
9,361 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,107 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Nguyen H TranPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
275 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and willing to sign a consent form.I am eligible for atezolizumab/bevacizumab as my first treatment.My liver cancer cannot be treated with surgery, transplant, or targeted therapies.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (68GA PSMA PET/CT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current participant count for this experiment?
"Affirmative. Information available on clinicaltrials.gov showcases that this medical study, first posted on January 25th 2022, is presently hunting for participants. The trial requires approximately 30 patients from a single site to be recruited."
Answered by AI
Are there presently vacancies available to enroll in this experiment?
"According to the clinicaltrials.gov website, this research project is currently attempting to find participants. The study was initially posted on January 25th 2022 and has been updated as of March 11th 2022."
Answered by AI
What adverse effects has Computed Tomography been associated with in patients?
"The safety rating of computed tomography, based on the assessments by Power's team, is 2. This ranking reflects that there is clinical evidence in support of its safety but not for efficacy as this study only encompasses Phase 2 trials."
Answered by AI
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