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18F-Labeled Picolinamide PET Imaging of Melanoma Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033485
Recruitment Status : Unknown
Verified January 2017 by Xijing Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE December 13, 2016
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date January 26, 2017
Estimated Study Start Date  ICMJE December 2017
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
SUV of organs and melanoma [ Time Frame: 1 hour after injection ]
The maximum standardized uptake values (SUVmax) with unit of g/mL of 18F-P3BZA and 18F-FDG in melanoma tissues.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-Labeled Picolinamide PET Imaging of Melanoma Diagnosis
Official Title  ICMJE 18F-Labeled Picolinamide PET-CT in the Management of Patients With Melanoma: The Radiation Dosimetry and Diagnostic Applications in Melanoma Patients
Brief Summary The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 18F labeled Picolinamide (18F-P3BZA) and preliminarily evaluate its diagnosis value in melanoma patients.
Detailed Description

50 patients with pathology diagnosed melanoma will be enrolled for the clinical study. If agree to take part in this study, the patient will be performed with 18F-P3BZA PET/CT scan and 18F-FDG PET/CT scan in the other day before and after surgery. Next, all of the resected tissues from the patients will be checked with pathology.

6 of 50 patients are performed for whole-body PET scans at 0, 15, 30, 45, 60, and 120 minutes and a CT scan at 60 minutes after tracer injection (mean dose, 5.0 ± 0.5 mCi in 2.0 ± 0.5ml) will be performed. During the imaging period, 1 mL blood samples will be obtained for time-activity curve calculations at 1, 5, 10, 30,60, 90, 120, and 180 minutes after injection. The estimated radiation doses will be calculated by using OLINDA/EXM software.

The images produced by these scans will be compared to see the diagnosis value of 18F-P3BZA.

Screening Tests:

Women who decide to take part in this study will be asked if they think they might be pregnant at the start of the study. All of them must have a negative blood pregnancy test (Human chorionic gonadotropin, HCG).

PET-CT Scan Procedure:

Before the PET-CT scan is performed, patient will be asked to remove any metallic objects when she/he arrive at the PET-CT Center. After a property rest, he/she will be injected with about 5mCi 18F-P3BZA. The first scan will take at 60 minutes after injection and a delay scan will take at 120 minutes after injection. Each PET/CT scan will take about 20 minutes.

After 18F-P3BZA scan, the patient will be asked to avoid stressful exercise. Starting about 12 hours before 18F-FDG scan, he/she will be asked to limit the amount of carbohydrates until the scans are done.

Follow-Up Visits:

Patients' primary care physician will follow-up them for next 24 hours. After then, they may order additional imaging or surgical results after this study for follow-up purposes. The study doctor will review these results to compare them with the PET-CT images. The study doctors will also review the results of any biopsies you may have had as a result of PET-CT findings.

This is an investigational study. PET-CT and CT scans are FDA approved and commercially available.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Melanoma
Intervention  ICMJE Radiation: 18F-P3BZA
18F-P3BZA is a type of 18F labeled Picolinamide targeting melanin which is highly secreted in Melanoma. The toxicity of P3BZA was evaluated by SoBran Bioscience. The final report showed that there no signs of toxicity during the conduct of the toxicity study. No treatment-related differences were noted in mean body weight and body weight changes, clinical chemistry, haematology, or coagulation parameter after a single intravenous dose of P3BZA at 0.0589mg/kg.
Other Name: 18F labeled Picolinamide
Study Arms  ICMJE Experimental: Melanoma patients
Melanoma patients enrolled for the clinical diagnosis study are performed with both 18F-P3BZA PET/CT and18F-FDG PET/CT scans before surgery.
Intervention: Radiation: 18F-P3BZA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with melanoma: diagnosed by pathology and ready for surgery

Exclusion Criteria:

  • patients with melanoma: refuse or cannot endure surgery
  • pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033485
Other Study ID Numbers  ICMJE KY20151230-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xijing Hospital
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP