Clinical Trials Logo
  1. Home
  2. Tumor
  3. NCT04525612
  4. Details
NCT04525612 Clinical Trial

68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer

Tumor Clinical Trial

Official title:
68Ga-BNU-PSMA PET/CT in Patients With Various Types of Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04525612
Other study ID # FirstAHFujian5
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date August 21, 2020
Est. completion date December 30, 2022

Study information
Verified date September 2020
Source First Affiliated Hospital of Fujian Medical University
Contact Weibing Miao, MD
Phone 86-0591-87981618
Email miaoweibing@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the potential usefulness of 68Ga-BNU-PSMA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Description:

Subjects with various types of cancer underwent 68Ga-BNU-PSMA PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-BNU-PSMA PET/CT were calculated.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- (i) adult population (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-BNU-PSMA PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee; (v) healthy volunteers(aged 18 years or order).

Exclusion Criteria:

- (i) patients with pregnancy; (ii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• 68Ga-BNU-PSMA
Each patient receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT scan within specified time.

Locations
Country Name City State
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Standardized uptake value (SUV) Standardized uptake value (SUV) of 68Ga-BNU-PSMA for each target lesion of subject or suspected primary tumor or/and metastasis. 30 days
Secondary Diagnostic efficacy The sensitivity, specificity and accuracy of 68Ga-BNU-PSMA PET/CT were calculated. 30 days
Secondary Diagnostic efficacy The positive predictive value (PPV), negative predictive value (NPV) 30 days
See also
  Status Clinical Trial Phase
Recruiting NCT04848376 - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting NCT05470283 - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma Phase 1
Completed NCT05041920 - A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects Phase 1
Recruiting NCT04430361 - the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy Phase 2
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Not yet recruiting NCT05549557 - IMM40H Phase I Dose Escalation and Expansion Phase 1
Terminated NCT01846429 - Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain Phase 1
Completed NCT01946555 - Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain N/A
Recruiting NCT01093079 - Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes N/A
Recruiting NCT01387971 - Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders N/A
Recruiting NCT00690261 - The Impact of M1/M2 Tumor Associated Macrophage (TAM) Polarization on Cancer Progression and Prognosis Prediction N/A
Completed NCT00561795 - Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors Phase 2
Completed NCT00413322 - Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors Phase 1
Completed NCT00152659 - Developing Criteria for Cortical Resections
Completed NCT00777751 - Radiation Therapy and Cardiac Enzymes N/A
Not yet recruiting NCT06109896 - Clinical Stories and Psychological Experiences of Cancer Patients
Not yet recruiting NCT05879146 - Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study Phase 2
Recruiting NCT02810405 - Collection of Tissue Blocks or Slides From Patients With Cancer
Recruiting NCT01867268 - Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence Phase 2
Terminated NCT01720745 - Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA