[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05556473":3,"trial-entities:NCT05556473":110,"trial-summary:NCT05556473":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":48,"sex":55,"minimum_age":56,"maximum_age":15,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":82,"locations":85,"central_contacts":101,"overall_officials":104,"references":108,"see_also_links":109},"NCT05556473","2022-010","F-Tryptophan PET\u002FCT in Human Cancers","A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET\u002FCT Imaging In Human Cancers","RECRUITING","2027-12-31","2026-01","2026-01-23","2022-09-29","Barbara Ann Karmanos Cancer Institute","OTHER",null,"Imaging procedures such as 1-(2-\\[18F\\]FLUOROETHYL)-L-Tryptophan PET\u002FCT 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\u002FCT in patients with cancers; specifically, to evaluate whether the tumors show increased tracer uptake as compared to non-tumor tissues, using F-Tryp PET\u002FCT. 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.",[19,20,21,22,23],"Intracranial Glioma","Metastatic Brain Tumor","Breast Cancer","Neuroendocrine Tumors","Rectal Cancer",[],"INTERVENTIONAL","DIAGNOSTIC",[28],"PHASE1",{"count":30,"type":31},24,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","1-(2-[18F]FLUOROETHYL)-L-Tryptophan","Radioactive tracer 1-(2-\\[18F\\]FLUOROETHYL)-L-Tryptophan 0.14mCi\u002Fkg\u002F5MBq\u002Fkg injection given one time prior to PET Scan.",[38],"[18F]FETrp PET radiotracer",[38],[41,45],{"measure":42,"description":43,"timeFrame":44},"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\u002FCT 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)",{"measure":46,"description":47,"timeFrame":44},"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\u002FCT imaging in the same breast tumor tissues, and the correlation of these two measures will be calculated.",[49,52],{"measure":50,"description":51,"timeFrame":44},"Radiation doses to the various organs.","Radiation doses received by the various organs (heart, lungs, pancreas, gallbladder, liver, small intestines, kidneys, muscle, bladder, ovaries\u002Ftestes) will be measured from the dynamic 1-(2-\\[18F\\]fluoroethyl)-L-tryptophan PET\u002FCT images. Mean and standard deviation of the radiation doses will be calculated for each organ.",{"measure":53,"description":54,"timeFrame":44},"Overall radiation dose to the study participants.","Overall radiation dose received by the study participants from the PET\u002FCT scan will be calculated from the dynamic 1-(2-\\[18F\\]fluoroethyl)-L-tryptophan PET\u002FCT images. Mean and standard deviation of the overall radiation dose will be calculated.","ALL","18 Years",false,{"inclusion":59,"exclusion":72,"raw_text":81},[60,61,62,63,64,65,66,67,68,69,70,68,71,68],"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\u002FCT scanner for at least 70 minutes while undergoing scanning.","Women of childbearing potential must not be pregnant or breastfeeding.","Recent anatomic imaging with visible disease (tumor) for comparison with the PET\u002FCT. .","Physical exam within 28 days of PET imaging, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST and ALT) within 14 days.","Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.","Histopathologically confirmed, well-differentiated metastatic neuroendocrine tumor.","ECOG performance status of 2 or better.","Patients receiving stable-dose somatostatin analogs (SSAs, long-acting release \\[LAR\\], depot) for \\>3 months before enrollment may be enrolled on the study, but such treatment is not required.","Clinical and radiological diagnosis of a breast cancer","Histologically confirmed colorectal cancer, which is located in the rectum.",[73,74,75,76,77,78,79,80],"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.","Ongoing treatment with a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide).","Use of telotristat ethyl (a tryptophan-hydroxylase inhibitor) within one month.","Recent (within 1 month) tumor resection or radio-chemotherapy (acute\u002Fsubacute post-treatment inflammatory changes may cause false positive increases on PET).","Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.","Inclusion Criteria:\n\n* Age ≥18 years.\n* Targeted lesion (tumor) is at least 1 cm in diameter as shown by clinical imaging.\n* Patient is able to lie in the PET\u002FCT scanner for at least 70 minutes while undergoing scanning.\n* Women of childbearing potential must not be pregnant or breastfeeding.\n* Recent anatomic imaging with visible disease (tumor) for comparison with the PET\u002FCT. .\n* Physical exam within 28 days of PET imaging, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST and ALT) within 14 days.\n* Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.\n\nInclusion Criteria Specific for Intracranial Tumors\n\n\\- 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.\n\nInclusion Criteria Specific for Extracranial Neuroendocrine Tumors:\n\n* Histopathologically confirmed, well-differentiated metastatic neuroendocrine tumor.\n* ECOG performance status of 2 or better.\n* Patients receiving stable-dose somatostatin analogs (SSAs, long-acting release \\[LAR\\], depot) for \\>3 months before enrollment may be enrolled on the study, but such treatment is not required.\n\nInclusion Criteria specific for Extracranial Primary Breast tumors:\n\n* Clinical and radiological diagnosis of a breast cancer\n* ECOG performance status of 2 or better.\n\nInclusion Criteria specific for Rectal tumors:\n\n* Histologically confirmed colorectal cancer, which is located in the rectum.\n* ECOG performance status of 2 or better.\n\nExclusion Criteria:\n\n* Patients who are pregnant or lactating are excluded.\n\nExclusion Criteria Specific for Intracranial Tumors:\n\n* Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention.\n* Tumor surgery or radiation within 1 month prior to the PET scan\n\nExclusion Criteria Specific for Extracranial Neuroendocrine Tumors:\n\n* Tumor-directed therapy within 3 months to the area of planned imaging.\n* Ongoing treatment with a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide).\n* Use of telotristat ethyl (a tryptophan-hydroxylase inhibitor) within one month.\n\nExclusion Criteria for Extracranial Primary Breast tumors:\n\n-Recent (within 1 month) tumor resection or radio-chemotherapy (acute\u002Fsubacute post-treatment inflammatory changes may cause false positive increases on PET).\n\nExclusion Criteria for Rectal tumors:\n\n-Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":98},"Karmanos Cancer Institute","Detroit","Michigan","48201","United States",[93],{"name":94,"role":95,"phone":96,"email":97},"Csaba Juhasz, MD, PhD","CONTACT","313-966-5136","csaba.juhasz@wayne.edu",{"lat":99,"lon":100},42.33143,-83.04575,[102],{"name":103,"role":95,"phone":96,"email":97},"Csaba Juhasz, M.D., Ph.D",[105],{"name":106,"affiliation":13,"role":107},"Csaba Juhasz, M.D.,Ph.D","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":117},[112,113,114,115,116],"Breast Carcinoma","Glioma","Malignant Brain Neoplasm","Neuroendocrine Neoplasm","Rectal Carcinoma",[],{"nct_id":4,"found":119,"summary":120,"prompt_version":130},true,{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 24 participants.","completed","F-Tryptophan PET\u002FCT for Various Cancers","This study is testing a new imaging method called F-Tryptophan PET\u002FCT to better see and understand different cancers, including brain tumors, breast cancer, and rectal cancer. Doctors want to see if tumor tissue takes up more of a special tracer called 1-(2-[18F]FLUOROETHYL)-L-Tryptophan compared to healthy tissue. This could help them tell the difference between tumors and normal tissue more clearly. You might be able to join if you are 18 or older, have a tumor at least 1 cm in size that can be seen on imaging, and can lie still for about 70 minutes during a PET\u002FCT scan. The study aims to see how well this tracer highlights tumors and how it moves through the body. The current status of the study is unclear.","The primary measurements are taken during the procedure, from right after tracer injection to 1-hour post-injection.",125,"You would receive a one-time injection of the radioactive tracer 1-(2-[18F]FLUOROETHYL)-L-Tryptophan and then undergo a PET\u002FCT scan for at least 70 minutes.","Not stated in the trial record.",[35],"v2"]