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68Ga-DOTATATE PET Scan for Neuroendocrine Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Ochsner Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance score greater than 50
Females of childbearing potential must have a negative pregnancy test at screening/baseline
Must not have
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT, and MRI that will result
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is testing a new way to scan for neuroendocrine cancer, which is often undetected by other methods. The new scan (68Ga-DOTATATE PET) will be compared to regular imaging methods to see if it is more effective.
Who is the study for?
Adults with neuroendocrine tumors or suspected positive tumors, who can consent and have a moderate level of physical function. Women must not be pregnant. Excluded are those with high creatinine or liver enzyme levels, severe allergies to IV contrast, recent use of investigational products, serious illnesses that could affect participation, active infections, inability to stay still for imaging or fit into the scanner due to size.
What is being tested?
The trial is testing the safety and effectiveness of a new PET scan using 68Ga-DOTATATE compared to standard imaging methods in detecting neuroendocrine tumors. Patients will receive an injection of this tracer dose radiopharmaceutical for tumor imaging.
What are the potential side effects?
Potential side effects may include reactions related to the intravenous injection such as pain at the injection site or allergic reactions. Since it's an imaging agent used in very low doses for scanning purposes only, significant side effects are uncommon.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to live at home and care for most of my personal needs.
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I am capable of becoming pregnant and have a negative pregnancy test.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot stay still for long periods due to a condition like severe arthritis.
Select...
I weigh less than 400 pounds and can fit into a PET/CT scanner.
Select...
I currently have an active infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
1Treatment groups
Experimental Treatment
Group I: ScanExperimental Treatment1 Intervention
We will perform 68Ga-DOTATATE PET scans on subjects.
Find a Location
Who is running the clinical trial?
Ochsner Health SystemLead Sponsor
94 Previous Clinical Trials
184,861 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to live at home and care for most of my personal needs.Your blood creatinine level is higher than 2.0 mg/dL.I cannot stay still for long periods due to a condition like severe arthritis.I am capable of becoming pregnant and have a negative pregnancy test.My tumor is suspected or confirmed to be neuroendocrine and shows up on specific scans.Your liver enzyme levels are more than three times the normal limit.I haven't had cancer treatment for any other type of cancer in the last 2 years.You have a serious allergy or extreme sensitivity to intravenous contrast dye used for imaging tests.I weigh less than 400 pounds and can fit into a PET/CT scanner.I am 18 years old or older.I currently have an active infection.
Research Study Groups:
This trial has the following groups:- Group 1: Scan
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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