F-Tryptophan PET/CT in Human Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Ann Karmanos Cancer Institute
About this trial
Imaging procedures such as 1-(2-\[18F\]FLUOROETHYL)-L-Tryptophan PET/CT in patients with cancers may help doctors assess a patient's response to treatment and help plan the best treatment in the future. The purpose is to see if there can be a better differentiation of tumor and non-tumor tissue where the tumor tissue has a higher uptake of Tryptophan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Targeted lesion (tumor) is at least 1 cm in diameter as shown by clinical imaging.
Patient is able to lie in the PET/CT scanner for at least 70 minutes while undergoing scanning.
Women of childbearing potential must not be pregnant or breastfeeding.
Disqualifiers
Patients who are pregnant or lactating are excluded.
Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention.
Tumor surgery or radiation within 1 month prior to the PET scan
Tumor-directed therapy within 3 months to the area of planned imaging.
Trial design
Design model
Single group
Treatments tested in this trial
1-(2-[18F]FLUOROETHYL)-L-Tryptophan
DrugRadioactive tracer 1-(2-\[18F\]FLUOROETHYL)-L-Tryptophan 0.14mCi/kg/5MBq/kg injection given one time prior to PET Scan.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: [18F]FETrp PET radiotracerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The percent difference in tracer uptake values between the tumor mass and the background (non-tumor tissue)
The percent difference in 1-(2-\[18F\]fluoroethyl)-L-tryptophan tracer standardized uptake values, measured between tumor and non-tumor (normal) tissues by PET/CT imaging, in each subject, will be calculated. Mean and standard deviation of the percent differences will be calculated for each tumor type.
Time frame
During procedure (from right after tracer injection to 1-hour post-injection)2
Correlation between the 1-(2-[18F]fluoroethyl)-L-tryptophan tracer uptake values and the tracer transport rates measured in the same breast tumor tissue.
The 1-(2-\[18F\]fluoroethyl)-L-tryptophan tracer standardized uptake values and the volume of distribution (characterizing the tracer transport rates) will be measured by PET/CT imaging in the same breast tumor tissues, and the correlation of these two measures will be calculated.
Time frame
During procedure (from right after tracer injection to 1-hour post-injection)Secondary outcomes
1
Radiation doses to the various organs.
Radiation doses received by the various organs (heart, lungs, pancreas, gallbladder, liver, small intestines, kidneys, muscle, bladder, ovaries/testes) will be measured from the dynamic 1-(2-\[18F\]fluoroethyl)-L-tryptophan PET/CT images. Mean and standard deviation of the radiation doses will be calculated for each organ.
Time frame
During procedure (from right after tracer injection to 1-hour post-injection)2
Overall radiation dose to the study participants.
Overall radiation dose received by the study participants from the PET/CT scan will be calculated from the dynamic 1-(2-\[18F\]fluoroethyl)-L-tryptophan PET/CT images. Mean and standard deviation of the overall radiation dose will be calculated.
Time frame
During procedure (from right after tracer injection to 1-hour post-injection)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Barbara Ann Karmanos Cancer Institute
Lead sponsor
Washington University School of Medicine
Collaborator
Source ClinicalTrials.gov