MelanomaNCT03033485
18F-Labeled Picolinamide PET Imaging of Melanoma Diagnosis
A study testing 18F-P3BZA in people with Melanoma, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma
- What is being tested?
- 18F-P3BZA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with melanoma: diagnosed by pathology and ready for surgery
Who cannot join
- patients with melanoma: refuse or cannot endure surgery
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-Labeled Picolinamide PET-CT in the Management of Patients With Melanoma: The Radiation Dosimetry and Diagnostic Applications in Melanoma Patients
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.
Read the 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.
- Conditions
- Melanoma
- Being tested
- 18F-P3BZA
- Keywords
- Picolinamide, PET/CT, Diagnosis, Melanoma
- Medical subject headings
- Melanoma, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-P3BZARadiation
Also called 18F labeled Picolinamide
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: 18F-P3BZA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startDec 2017 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033485
- Sponsor's protocol ID
- KY20151230-1
- Status last verified
- Jan 2017
- First submitted
- 13 Dec 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Labeled Picolinamide PET-CT in the Management of Patients With Melanoma: The Radiation Dosimetry and Diagnostic Applications in Melanoma Patients
- ClinicalTrials.gov ID
- NCT03033485
- Acronym / sponsor ID
- KY20151230-1
- Conditions
- Melanoma
- Keywords
- Picolinamide, PET/CT, Diagnosis, Melanoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma patients | Experimental | Radiation: 18F-P3BZAMelanoma patients enrolled for the clinical diagnosis study are performed with both 18F-P3BZA PET/CT and18F-FDG PET/CT scans before surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with melanoma: diagnosed by pathology and ready for surgery
Key exclusion criteria (2 listed)
- patients with melanoma: refuse or cannot endure surgery
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-P3BZAAlso: 18F labeled Picolinamide18F-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. | Radiation | Melanoma patients |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-P3BZA in people with Melanoma, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang, M.D, Ph.D (86-29-84775449, wangjing@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV of organs and melanoma (time frame: 1 hour after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.