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F-Tryptophan PET/CT Imaging for Cancer
Phase 1
Recruiting
Led By Csaba Juhasz, M.D.,Ph.D
Research Sponsored by Barbara Ann Karmanos Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure (from right after tracer injection to 1-hour post-injection)
Awards & highlights
Study Summary
This trial is testing a new imaging procedure that may help doctors better assess a patient's response to cancer treatment and plan future treatment.
Who is the study for?
Adults over 18 with certain cancers (brain, breast, neuroendocrine, colorectal) and visible tumors at least 1cm in diameter. Participants must be able to undergo a PET/CT scan for 70 minutes and not be pregnant or breastfeeding. They should have an ECOG performance status of ≤2 and meet specific criteria based on their cancer type.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a new imaging procedure using F-Tryptophan PET/CT to distinguish between tumor tissue and non-tumor tissue in various cancers. The goal is to improve treatment planning by better identifying how tumors take up Tryptophan.See study design
What are the potential side effects?
As this trial focuses on an imaging technique rather than a drug intervention, side effects are minimal but may include discomfort from lying still during the scan or reactions related to contrast agents if used.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedure (from right after tracer injection to 1-hour post-injection)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure (from right after tracer injection to 1-hour post-injection)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Breast
The percent difference in tracer uptake values between the tumor mass and the background (non-tumor tissue)
Secondary outcome measures
Overall radiation dose to the study participants.
Radiation doses to the various organs.
Side effects data
From 2019 Phase 2 & 3 trial • 93 Patients • NCT0206797519%
Nausea
11%
Vomiting
6%
Sedation
6%
Dizziness
3%
Headache
3%
Abdominal Pain
3%
Syncope
3%
Drowsniess
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Control: Tryptophan
Schizophrenia Related Disorders: Tryptophan
Healthy Controls: Placebo
Schizophrenia Related Disorders: Placebo
Healthy Controls: Screening
Schizophrenia Related Disorders: Screening
Trial Design
1Treatment groups
Experimental Treatment
Group I: [18F]FETrp PET radiotracerExperimental Treatment1 Intervention
All participants will receive the tracer to evaluate the uptake of [18F]FETrp PET/CT on intra- and extracranial cancers.
Find a Location
Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,232 Total Patients Enrolled
17 Trials studying Breast Cancer
1,199 Patients Enrolled for Breast Cancer
Washington University School of MedicineOTHER
1,936 Previous Clinical Trials
2,299,828 Total Patients Enrolled
46 Trials studying Breast Cancer
5,144 Patients Enrolled for Breast Cancer
Csaba Juhasz, M.D.,Ph.DPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a well-differentiated neuroendocrine tumor that has spread.I am currently on medication specifically for my cancer.I had tumor surgery or radiation less than a month before my PET scan.I have not taken telotristat ethyl in the last month.I haven't had cancer treatment in the area to be imaged in the last 3 months.I am not pregnant or breastfeeding.I've had a physical exam and blood tests within the last month.I can stay still in a scanner for over an hour.I can walk and take care of myself without help.My cancer is confirmed to be in the rectum and is colorectal.I am 18 years old or older.I have been diagnosed with breast cancer through exams and imaging.I have a brain lesion suspected to be a tumor, as seen on MRI.I haven't had tumor surgery or radio-chemotherapy in the last month.I have active Crohn's or Ulcerative colitis affecting my rectum.I do not have severe brain pressure or seizures needing urgent care.I have been on a stable dose of somatostatin analogs for over 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: [18F]FETrp PET radiotracer
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 recruitment efforts open for this clinical trial?
"According to clinicaltrials.gov, this medical trial is currently recruiting participants. The research team initially posted the project information on October 1st 2022 and finalized their revisions on September 22nd 2022."
Answered by AI
What is the aggregate amount of people entering this experiment?
"Affirmative. As indicated on clinicaltrials.gov, this medical research is currently enlisting participants and has been since October 1st 2022. Additionally, the project seeks to recruit 19 individuals from a single site."
Answered by AI
Does the administration of [18F]FETrp PET radiotracer pose any health risks to individuals?
"As this is just a Phase 1 clinical trial for [18F]FETrp PET radiotracer, there is limited evidence to suggest its safety and efficacy - thus earning it a score of 1."
Answered by AI
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