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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]FETrp PET radiotracer | Experimental | All participants will receive the tracer to evaluate the uptake of [18F]FETrp PET/CT on intra- and extracranial cancers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1-(2-[18F]FLUOROETHYL)-L-Tryptophan | Drug | Radioactive tracer 1-(2-[18F]FLUOROETHYL)-L-Tryptophan 0.14mCi/kg/5MBq/kg injection given one time prior to PET Scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure (from right after tracer injection to 1-hour post-injection) |
| 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. | During procedure (from right after tracer injection to 1-hour post-injection) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During procedure (from right after tracer injection to 1-hour post-injection) |
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Inclusion Criteria:
Inclusion Criteria Specific for Intracranial Tumors
- Clinical and MRI diagnosis of an intracranial lesion suspicious for a brain tumor, including gliomas or metastatic brain tumors; primary, residual, or recurrent brain tumors (judged by clinical imaging) will qualify.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Csaba Juhasz, M.D., Ph.D | Contact | 313-966-5136 | csaba.juhasz@wayne.edu |
| Name | Affiliation | Role |
|---|---|---|
| Csaba Juhasz, M.D.,Ph.D | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D001943 | Breast Neoplasms |
| D018358 | Neuroendocrine Tumors |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. | During procedure (from right after tracer injection to 1-hour post-injection) |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |