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Trial record 5 of 2318 for:    melanoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03033485
Recruitment Status : Not yet recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Melanoma Radiation: 18F-P3BZA

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F‐Labeled Picolinamide PET-CT in the Management of Patients With Melanoma: The Radiation Dosimetry and Diagnostic Applications in Melanoma Patients
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with melanoma: refuse or cannot endure surgery
  • pregnant women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033485


Contacts
Contact: Jing Wang, M.D, Ph.D 86-29-84775449 wangjing@fmmu.edu.cn
Contact: Xiaowei Ma, M.D 86-29-84771048 mxw_cn@hotmail.com

Locations
China, Shaanxi
Xijing Hospital Nuclear Medicine Department
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
More Information

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03033485     History of Changes
Other Study ID Numbers: KY20151230-1
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xijing Hospital:
Picolinamide
PET/CT
Diagnosis
Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas