Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT07254104
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-11-28
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of [68Ga]Ga-NOTA-RF PET Imaging Targeting RFVT3 in Patients With Pituitary Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SUVmax', 'timeFrame': 'After the completion of the PET examination.', 'description': 'The tumor uptake capacity (expressed as SUV values) of \\[68Ga\\]Ga-NOTA-RF PET imaging in intracranial tumors.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pituitary Neoplasms']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the clinical application value of \\[68Ga\\]Ga-NOTA-RF, a novel PET molecular probe targeting riboflavin transporter 3 (RFVT3), in patients with pituitary adenomas. It will observe the probe's imaging characteristics, distribution signs, and the relationships between these factors, tumor differentiation degree, and radiotracer uptake. Additionally, the study will explore the diagnostic advantages of \\[68Ga\\]Ga-NOTA-RF in patients with pituitary adenomas and its potential value in precise typing.", 'detailedDescription': 'This study aims to evaluate the potential clinical application of \\[68Ga\\]Ga-NOTA-RF in pituitary adenomas. Such tumors are characterized by variable degrees of differentiation, subtle early morphological changes, complex metabolic states, and a strong dependence on mitochondrial activity. Existing imaging modalities have limited performance in detecting and characterizing these lesions, highlighting the need for novel metabolic imaging tools. This study will systematically investigate the biodistribution and imaging characteristics of \\[68Ga\\]Ga-NOTA-RF in pituitary adenomas, as well as its correlation with RFVT3 expression, to explore its potential value in early tumor detection, metabolic subtype differentiation, and molecular classification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 18 and 80 years, male or female.\n2. Able to understand and sign written informed consent, willing to follow pre-injection preparation requirements (adequate hydration and avoidance of high-dose riboflavin supplements), and to complete all study procedures.\n3. Recurrent invasive pituitary adenoma within 6 months after surgery, without intracranial or distant metastasis. The postoperative pathological Ki-67 index of the previous pituitary tumor is ≥3%, and tumor growth cannot be controlled by standard medical therapy and radiotherapy.\n4. Radiological and clinical evidence indicates residual or recurrent pituitary adenoma requiring treatment or follow-up management.\n5. At least one measurable and resectable lesion suitable for correlation with PET imaging evaluation; vital signs are stable, and the participant is able to lie supine and cooperate during a 30-60 minute PET scan.\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant, or breastfeeding women.\n2. Known history of severe allergic or anaphylactoid reactions to any component of the investigational tracer (riboflavin derivatives, NOTA chelator, or formulation excipients).\n3. Presence of severe or uncontrolled medical conditions (e.g., decompensated heart failure, active infection, myocardial infarction or stroke within the past 4 weeks) that, in the opinion of the investigator, make the participant unsuitable for PET imaging.\n4. Concomitant severe systemic diseases such as cardiac, pulmonary, hepatic, or renal failure.\n5. Pituitary adenoma patients who underwent surgery less than 4 weeks prior to enrollment or completed radiotherapy to the sellar region within the past 3 months.\n6. Participation in another interventional clinical trial within the past 4 weeks, or cumulative radiation exposure from prior research procedures within the past 12 months that may exceed the ethical safety limit.\n7. Severe claustrophobia unrelieved by sedation, or any other condition that would prevent completion of the PET scan.\n8. Poor compliance or any factor judged by the investigator to affect the participant's safety or the quality of study data.\n9. Any other condition that, in the judgment of the investigator, makes the participant unsuitable for study participation."}, 'identificationModule': {'nctId': 'NCT07254104', 'briefTitle': 'Clinical Evaluation of [68Ga]Ga-NOTA-RF PET Imaging Targeting RFVT3 in Patients With Pituitary Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Clinical Evaluation of [68Ga]Ga-NOTA-RF PET Imaging Targeting RFVT3 in Patients With Pituitary Tumors', 'orgStudyIdInfo': {'id': 'PUMCH-RFVT3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pituitary Neoplasms', 'description': 'Participants with pituitary neoplasms will undergo \\[68Ga\\]Ga-NOTA-RF PET/CT imaging to evaluate tracer uptake, biodistribution, and safety.', 'interventionNames': ['Drug: [68Ga]Ga-NOTA-RF']}], 'interventions': [{'name': '[68Ga]Ga-NOTA-RF', 'type': 'DRUG', 'otherNames': ['[68Ga]Ga-RF PET tracer'], 'description': 'Administer the \\[68Ga\\]Ga-NOTA-RF radiotracer via injection.', 'armGroupLabels': ['Pituitary Neoplasms']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xianzhong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xianzhong Zhang', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}