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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

No Placebo-Only Group

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.

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.

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from study registration to disease progression per recist 1.1 and per psma pet/ct, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival (PFS)

Time to progression

Time to treatment response

Side effects data

From 2023 Phase 2 trial • 257 Patients • NCT01333033

79%

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

Hypotension

Insomnia

Esophageal pain

Esophagitis

Chills

Weight loss

Hyperglycemia

Hypocalcemia

Arthralgia

Hypoalbuminemia

Sinus tachycardia

Pain

Bloating

Constipation

Hypokalemia

Peripheral sensory neuropathy

Aspiration

Alopecia

Skin and subcut tissue disord - Oth spec

Febrile neutropenia

Pharyngolaryngeal pain

Soft tissue infection

Hypoxia

Hypophosphatemia

Depression

Dysgeusia

Gastroparesis

Pain in extremity

Edema limbs

Stomach pain

Cardiac arrest

Thrombotic thrombocytopenic purpura

Esophageal hemorrhage

Esophageal obstruction

Lung infection

Sepsis

Tooth infection

Alkaline phosphatase increased

Back pain

Atelectasis

Cough

Epistaxis

Hiccups

Hoarseness

Pleural effusion

Pleuritic pain

Rash maculo-papular

Hypertension

Phlebitis

Superficial thrombophlebitis

Vascular disorders - Other, specify

Thromboembolic event

Blood and lymph sys disorders - Oth Spec

Palpitations

Sinus bradycardia

100%

80%

60%

40%

20%

Study treatment Arm

FOLFOX Non-Responder

CP Responder

FOLFOX Responder

CP Non-Responder

CP No Cross-over

FOLFOX No Cross-over

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Positron Emission Tomography

2011

Completed Phase 2

~2200

Gallium Ga 68 Gozetotide

2021

Completed Phase 3

~1770