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Radiopharmaceutical
AWSM-PET Technique vs Standard PET/CT for Cancer Detection
N/A
Recruiting
Led By Yuan-Chuan Tai, Ph.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patient 18 years of age or older
Patients of child-bearing potential must have a negative urine pregnancy test on the day of the PET/CT scan. Postmenopausal women who self-report as amenorrheic for at least 12 consecutive months are to be considered not of child-bearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study (estimated to be 30 months)
Awards & highlights
Study Summary
This trial will test whether a new PET/CT technology can improve the accuracy of detecting small malignant lesions in cancer patients.
Who is the study for?
This trial is for adults over 18 with suspected or confirmed carcinoma who need a PET/CT scan. They must understand and consent to the study, possibly undergo biopsy or surgery before other treatments, and be able to lie still for about 30 minutes during imaging. Women of childbearing age need a negative pregnancy test.Check my eligibility
What is being tested?
The AWSM-PET technique's ability to detect malignant lesions in cancer patients is being compared against the standard FDG PET/CT scans. The goal is to see if AWSM-PET can provide better image resolution and sensitivity, especially for very small lesions.See study design
What are the potential side effects?
While not explicitly listed, side effects may include discomfort from lying still during imaging and potential risks associated with exposure to radiation from the PET/CT scans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am not pregnant or have been amenorrheic for at least 12 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of study (estimated to be 30 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study (estimated to be 30 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Image reading of each lesion on AWSM-PET
Image reading of each lesion on SOC FDG-PET/CT
Malignant Neoplasms
Secondary outcome measures
Image quality score
To assess whether a nuclear medicine physician's confidence is altered by the AWSM-PET technology
Tolerability as measured by number of patients who find the scan intolerable and have to terminate the study
+1 moreSide effects data
From 2015 Phase 2 trial • 42 Patients • NCT0067143767%
Rach - acneiform
62%
Albumin (low)
62%
Lymphocytes (low)
50%
Hemoglobin (low)
43%
Calcium (low)
36%
Fatigue
33%
Sodium (low)
33%
Magnesium (low)
31%
Nausea
21%
Creatinine (high)
21%
Infection skin - ungual
21%
SGPT (ALT-high)
21%
Glucose (high)
21%
INR (high)
19%
Potassium (low)
19%
PTT (high)
17%
Constipation
17%
Dry skin
17%
Weight loss
14%
Alkaline phosphatase (high)
14%
SGOT (AST - high)
12%
Diarrhea
12%
Sodium (high)
12%
Potassium (high)
12%
Pain - tumor
10%
Dyspnea (shortness of breath)
10%
Edema - limb
10%
Mucositis
10%
Allergic reaction/hypersensitivity
7%
Leukocytes (low)
7%
Infection normal ANC - skin
7%
Rash/desquamation
7%
Glucose (low)
7%
Phosphate (low)
7%
Hemorrhage: Tumor Site
7%
Pain - musculoskeletal - neck
7%
Anorexia
5%
Bilirubin (hyperbilirubinemia)
5%
Dehydration
5%
Pain - back
5%
Platelets (low)
5%
Rash - trach site
5%
Vomiting
5%
Cough
5%
Infection normal ANC - upper respiratory
5%
Infection normal ANC - cellulitis
5%
Headache
5%
Hypoxia
5%
Edema - head and neck
5%
Magnesium (high)
5%
Calcium (high)
2%
Bronchospasm/Wheezing
2%
Death - Disease Progression
2%
Infection lung - pneumonia
2%
Lymphocytes (decreased)
2%
Brachial plexopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1 (Cetuximab)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)Experimental Treatment3 Interventions
All enrolled subjects will undergo SOC FDG-PET/CT scan with an AWSM PET device positioned at the far end of the Biograph Vision PET/CT scanner. The patient will receive 10-20 mCi FDG injection according to the SOC FDG-PET/CT protocol dosing schedule. The entire study will require approximately 2 ½ - 3 hours (from the time patient arrives to the completion of the scan).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FDG-PET/CT
2010
Completed Phase 2
~410
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,934 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,312 Total Patients Enrolled
Yuan-Chuan Tai, Ph.D.Principal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My fasting blood sugar level is not above 200 mg/dL.I am 18 years old or older.I am not pregnant or have been amenorrheic for at least 12 months.I can stay still for about 30 minutes for a scan.I am scheduled for a PET/CT scan for cancer diagnosis, staging, or suspected recurrence and may have a biopsy or surgery before other treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Augmented Whole-body Scanning via Magnifying PET (AWSM-PET)
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.
Are there any ongoing recruitment opportunities for this clinical trial?
"Unfortunately, the clinical trial has concluded its search for patients as per data on clinicaltrials.gov; The original posting was made on December 31st 2022 and it was last updated November 15th of that same year. However, there are currently 486 other trials actively recruiting participants at this time."
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