Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 10:28 AM
Study NCT ID:
NCT04147494
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2019-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706531', 'term': 'FAPI-46'}, {'id': 'C000718244', 'term': 'gallium 68 PSMA-11'}, {'id': 'C000622699', 'term': '68Ga-DKFZ-PSMA-11'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2031-10-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Additional correlation of biodistribution of standard of care tracer', 'timeFrame': '60 minutes after tracer injection', 'description': 'assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan'}], 'primaryOutcomes': [{'measure': 'To define and document the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies', 'timeFrame': '60 minutes after tracer injection', 'description': 'To quantify tumor tissue and normal background organs positron emission tomography (PET) tracer uptake by semi-quantitative analysis (unit/metrics = standardized uptake values (SUV)). The 68Ga-PSMA-11 and 68Ga-FAPI-46 tracer biodistribution will be described by mean and maximum standardized uptake values (SUVmean and SUVmax).'}], 'secondaryOutcomes': [{'measure': '68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation', 'timeFrame': 'From date of imaging to date of surgery (range 1-60 days)', 'description': 'To evaluate whether 68Ga-FAPi-46 accumulation observed by PET correlates with the amount of FAP in excised cancer tissue as assessed by immunohistochemistry (IHC).'}, {'measure': 'evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution', 'timeFrame': 'up to 2 years', 'description': '2\\. To evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution (when available) to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Carcinoma', 'Colon Carcinoma', 'Esophageal Carcinoma', 'Gastric Carcinoma', 'Head and Neck Carcinoma', 'Kidney Carcinoma', 'Lung Carcinoma', 'Ovarian Carcinoma', 'Pancreatic Carcinoma', 'Solid Neoplasm', 'Uterine Corpus Cancer']}, 'referencesModule': {'references': [{'pmid': '36512649', 'type': 'DERIVED', 'citation': 'Kunikowska J, Bizon M, Pelka K, Derlatka P, Olszewski M, Krolicki L. 68 Ga-Prostate-Specific Membrane Antigen PET/CT in Ovarian Tumors : Potential to Differentiate Benign and Malignant Tumors Before Surgery: A Preliminary Report. Clin Nucl Med. 2023 Feb 1;48(2):e60-e66. doi: 10.1097/RLU.0000000000004486. Epub 2022 Nov 18.'}]}, 'descriptionModule': {'briefSummary': "This phase I trial studies a new imaging technique called FAPi PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) accumulate in normal and cancer tissues in patients with non-prostate cancer. The research team also want to know whether what they see on PET/CT images represents the tumor tissue being excised from the patient's body. The research team is also interested to investigate another new imaging technique called PSMA PET/CT. Participants will be invited to undergo another PET/CT scan, with the PSMA tracer (68Ga-PSMA-11). This is not required but just an option for volunteer patients. Patients who have not received an 18F-FDG PET/CT within one month of enrollment will also undergo an FDG PET/CT scan. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, 68Ga-PSMA-11 and 68Ga-FAPi, and 18F-FDG (if applicable). Because some cancers take up 68Ga-PSMA-11 and/or 68Ga-FAPi it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs where it occurs in patient's body. FAP stands for Fibroblast Activation Protein. FAP is produced by cells that surround tumors. The function of FAP is not well understood but imaging studies have shown that FAP can be detected with FAPI PET/CT. Imaging FAP with FAPI PET/CT may in the future provide additional information about various cancers. PSMA stands for Prostate Specific Membrane Antigen. This name is incorrect as PSMA is also found in many other cancers. The function of PSMA is not well understood but imaging studies have shown that PSMA can be detected with PET in many non-prostate cancers. Imaging FAP with PET/CT may in the future provide additional information about various cancers.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To define the biodistribution of gallium Ga 68 FAPi-46 (68Ga-FAPi-46) and gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) in normal and cancer tissues of patients with various non-prostate malignancies. The goal is to determine where and to which degree 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulates in normal and cancer tissues.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate whether 68Ga-FAPi-46 and 68Ga-PSMA-11 accumulation observed by positron emission tomography (PET) correlates with the amount of fibroblast activation protein (FAP) and prostate specific membrane antigen (PSMA) in excised cancer tissue, respectively.\n\nII. To evaluate the 68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution (when available) to define the frequency of the following phenotypes (FAP+/ FDG+, FAP-/ FDG+, FAP+/ FDG-, FAP-/ FDG-).\n\nEXPERIMENTAL OBJECTIVE:\n\nIII. Assess the 68Ga-FAPI-46 biodistribution correlation with 68Ga-PSMA-11, if the patient volunteers for optional scan, and 18F-fluodeoxyglucose (FDG), if any FDG PET/computed tomography (CT) has been performed as standard-of-care.\n\nOUTLINE:\n\nPatients receive 68Ga-FAPi-46 intravenously (IV) and undergo PET/CT scan over 20-50 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with the following cancer types:\n\n * Breast cancer\n * Colon cancer\n * Esophageal cancer\n * Gastric cancer\n * Head and Neck cancer\n * Lung cancer\n * Ovarian cancer\n * Pancreatic cancer\n * Renal cancer\n * Uterus cancer\n* Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis\n* Patient can provide written informed consent\n* Patient is capable of complying with study procedures\n* Patient is able to remain still for duration of imaging procedure (up to one hour)\n\nExclusion Criteria:\n\n* Patient is pregnant or nursing\n* Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT\n* Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data'}, 'identificationModule': {'nctId': 'NCT04147494', 'briefTitle': 'Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation', 'orgStudyIdInfo': {'id': '19-000756'}, 'secondaryIdInfos': [{'id': 'NCI-2019-07265', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)', 'description': 'Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable). Patients may also receive 68Ga-PSMA-11 IV and undergo PET/CT scan over 20-50 minutes on a separate day (for volunteer patients only, PSMA PET/CT is optional and not required).', 'interventionNames': ['Procedure: Computed Tomography', 'Radiation: Gallium Ga 68 FAPi-46', 'Radiation: Gallium Ga 68-labeled PSMA-11', 'Procedure: Positron Emission Tomography', 'Radiation: 18F-FDG']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'computerized tomography', 'CT', 'CT scan', 'tomography'], 'description': 'Undergo PET/CT scan', 'armGroupLabels': ['Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)']}, {'name': 'Gallium Ga 68 FAPi-46', 'type': 'RADIATION', 'otherNames': ['68Ga-FAPi-46', 'Gallium-68-FAPi-46'], 'description': 'Given IV', 'armGroupLabels': ['Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)']}, {'name': 'Gallium Ga 68-labeled PSMA-11', 'type': 'RADIATION', 'otherNames': ['(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC', '(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC', '(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC', '(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC', '(68Ga)Glu-urea-Lys(Ahx)-HBED-CC', '68Ga-DKFZ-PSMA-11', '68Ga-HBED-CC-PSMA', '68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC', '68Ga-PSMA', '68Ga-PSMA-11', '68Ga-PSMA-HBED-CC', '[68Ga] Prostate-specific Membrane Antigen 11', '[68Ga]GaPSMA-11', 'Ga PSMA', 'Ga-68 labeled DKFZ-PSMA-11', 'Ga-68 labeled PSMA-11', 'Gallium Ga 68 PSMA-11', 'Gallium-68 PSMA', 'Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC', 'GaPSMA', 'PSMA-HBED-CC GA-68'], 'description': 'Given IV', 'armGroupLabels': ['Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'positron emission tomography scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo PET/CT scan', 'armGroupLabels': ['Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)']}, {'name': '18F-FDG', 'type': 'RADIATION', 'otherNames': ['18F-fluorodeoxyglucose'], 'description': 'Given IV', 'armGroupLabels': ['Basic Science (68Ga-FAPi-46 PET/CT, 68Ga-PSMA-11 PET/CT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ethan Lam', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jeremie Calais, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA / Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Nuclear Medecine and Molecular Imaging', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}