Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Location status: Recruiting
NCT Number: NCT05556473
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Detroit, Michigan, 48201, United States
Location status: Recruiting
In this research study, we will compare the uptake of the tracer on F-Tryp PET/CT in patients with cancers; specifically, to evaluate whether the tumors show increased tracer uptake as compared to non-tumor tissues, using F-Tryp PET/CT. Additionally, we will evaluate the biodistribution (i.e. track where the tracer has traveled in the body) and radiation dosimetry (i.e., absorbed dose of tracer in tissue). These changes may be compared with results of the physical examination and scans (CT and MRI or standard clinical PET) that are done as part of routine clinical care or as part of other studies. Pictures (images) from the PET scan will be made showing the distribution throughout the body of substances containing a small amount of radioactive material.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
Specific for Intracranial Tumors
Inclusion criteria
Specific for Extracranial Neuroendocrine Tumors:
Inclusion criteria
specific for Extracranial Primary Breast tumors:
Inclusion criteria
specific for Rectal tumors:
Exclusion criteria
Exclusion criteria
Specific for Intracranial Tumors:
Exclusion criteria
Specific for Extracranial Neuroendocrine Tumors:
Exclusion criteria
for Extracranial Primary Breast tumors:
-Recent (within 1 month) tumor resection or radio-chemotherapy (acute/subacute post-treatment inflammatory changes may cause false positive increases on PET).
Exclusion criteria
for Rectal tumors:
-Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.
Radioactive tracer 1-(2-[18F]FLUOROETHYL)-L-Tryptophan 0.14mCi/kg/5MBq/kg injection given one time prior to PET Scan.
Other names: [18F]FETrp PET radiotracer
Time frame: During procedure (from right after tracer injection to 1-hour post-injection)
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)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
Barbara Ann Karmanos Cancer Institute
Other
A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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