18F-Labeled Picolinamide PET Imaging of Melanoma Diagnosis

NCT03033485 | Unknown

• 1 other identifier: KY20151230-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Picolinamide; PET/CT; Diagnosis; Melanoma

Outcome Measures

Primary Outcomes (1)

• SUV of organs and melanoma

  The maximum standardized uptake values (SUVmax) with unit of g/mL of 18F-P3BZA and 18F-FDG in melanoma tissues.

  1 hour after injection

Study Arms (1)

Melanoma patients

EXPERIMENTAL

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

Interventions

18F-P3BZA RADIATION

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.

Also known as: 18F labeled Picolinamide

Melanoma patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital Nuclear Medicine Department

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Melanoma; Disease

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jing Wang, M.D, Ph.D

CONTACT

86-29-84775449; wangjing@fmmu.edu.cn

Xiaowei Ma, M.D

CONTACT

86-29-84771048; mxw_cn@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 26, 2017
• Study Start: December 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)