MelanomaNCT00828126
PET-CT in the Management of Patients With Stage III or IV Metastatic Melanoma
An observational study of Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn how often using a positron emission tomography-computed tomography (PET-CT) scan in addition to a standard computed tomography (CT) scan will change the surgical plan in patients with metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- PET-CT Scan
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Mar 2012
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals over 18 years of age with metastatic melanoma (melanoma that has spread to other parts of the body) and are considered a candidate for surgery based on a contrast-enhanced computer tomography (CT) scan.
Who may be able to join
- AJCC Stage III melanoma with clinically evident (macroscopic) disease, either by physical examination or on conventional imaging, or AJCC stage IV melanoma with metastatic site(s) considered surgically resectable. The initial decision regarding surgical candidacy should be made by surgical oncologist. Patients with indeterminate CT findings that are larger than 1 cm outside of the field of the potential surgery will be also included.
- Contrast- enhanced CT of chest, abdomen and pelvis performed either at MDACC or outside of the institution should indicate surgical candidacy. Outside CT imaging studies should be of acceptable quality, as determined by the evaluating radiologist. PET-CT per protocol must be performed within 30 days from the contrast-enhanced CT.
- 3. Age >/= 18. All minor patients will be excluded to avoid excessive radiation dose. There is data suggesting small but statistically significant increased risk for secondary malignancy due to the cumulative dose of radiation exposure associated with diagnostic imaging. Children are most sensitive to radiation long term adverse effects. Therefore current pilot study will accrue adults only. If the result of this study will indicate potential advantage of PET-CT, this data can be weighted against radiation exposure risks to decide upon imaging strategies in pediatric patients with melanoma.
Who cannot join
- Regional disease limited to an involved sentinel lymph node (occult or microscopic regional nodal metastasis).
- Availability of prior PET-CT, performed within 60 days of initial clinical appointment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET-CT in the Management of Patients With Stage III Or IV Metastatic Melanoma Considered Candidates for Surgery: Evaluation of Additive Value Following Conventional Imaging
The goal of this clinical research study is to learn how often using a positron emission tomography-computed tomography (PET-CT) scan in addition to a standard computed tomography (CT) scan will change the surgical plan in patients with metastatic melanoma.
Read the detailed description
If you agree to take part in this study, you will have a PET-CT scan performed. The picture produced by this scan will be compared to a standard CT scan to see if any additional tumors can be located. If the study doctor thinks that additional tumors are present, a biopsy may need to be performed to check the status of the tumors. The type of biopsy will depend on where the tumor(s) are located on the body. If a biopsy is performed, you will sign a separate consent.
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. Women who are unsure if they may be pregnant or think that they may be pregnant must have a negative blood (about 1 teaspoon) pregnancy test.
PET-CT Scan Procedure:
Before the PET-CT scan is performed, you will be asked to avoid stressful exercise for 24 hours. Starting about 12 hours before the scan, you should eat a high protein diet and limit the amount of carbohydrates you eat. Starting about 6 hours before the scan, you should not eat or drink anything other than water (fast) until after the scan is done. You may continue to take prescribed drugs with water during the fasting period.
On the day of the PET-CT scan, you should wear comfortable clothing, preferably without metal buttons and/or zippers. You will be asked to remove any metallic objects you have when you arrive at the PET-CT Center.
- Blood (a few drops from the fingertip) will be collected to check your blood sugar levels.
- A radioactive sugar solution, called fluorodeoxyglucose (FDG), will be given through a needle in a vein of your arm. The injection will last about 5 minutes. Following the FDG injection, you will rest for about 1 hour to allow the FDG to move throughout the body. You will then be asked to urinate before the scan is performed.
You will lie flat on your back on the scanner table. The table will move slowly in and out of a donut-shaped machine called the PET-CT scanner. This scanner creates a picture that shows the FDG in the tumor(s) and organs. The scan takes about 45-60 minutes. You will need to lie as still as possible while the scan is being performed.
Length of Study:
Your participation on this study will be over after PET-CT scan has been completed.
Follow-Up Visits:
As a part of your standard of care, your primary care physician may order additional imaging after your completion of this study for follow-up purposes. The study doctor will review these images 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. The PET-CT component of this study is investigational because it is being done within a certain timeframe (within 30 days after your CT scan) instead of at the timeframe your doctor would normally decide.
Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson Cancer Center (MDACC).
- Conditions
- Melanoma
- Being tested
- PET-CT Scan
- Keywords
- Metastatic Melanoma, AJCC Stage III Melanoma, AJCC stage IV Melanoma, PET-CT, Positron Emission Tomography-Computed Tomography, Contrast-enhanced Computed Tomography Scan, CT, Conventional Imaging, False Positive Rate, Fluorodeoxyglucose, FDG, Surgery
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT ScanProcedure or surgery
Also called PET-CT
Positron emission tomography-computed tomography (PET-CT) scan performed within 30 days of contrast-enhanced CT.
| Study group | Role | What they receive |
|---|---|---|
| PET-CT Scan | Not described Receives: Procedure: PET-CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients in whom a change in surgical plan occurred based on PET-CT result
Measured: Evaluation following PET-CT performed within 30 days of contrast-enhanced CT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2012
- Study completionMar 2012
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 M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yulia Bronstein, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828126
- Sponsor's protocol ID
- 2008-0478
- Status last verified
- Mar 2012
- First submitted
- 13 Jan 2009
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-CT in the Management of Patients With Stage III Or IV Metastatic Melanoma Considered Candidates for Surgery: Evaluation of Additive Value Following Conventional Imaging
- ClinicalTrials.gov ID
- NCT00828126
- Acronym / sponsor ID
- 2008-0478
- Conditions
- Melanoma
- Keywords
- Metastatic Melanoma, AJCC Stage III Melanoma, AJCC stage IV Melanoma, PET-CT, Positron Emission Tomography-Computed Tomography, Contrast-enhanced Computed Tomography Scan, CT, Conventional Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Jan 2009 (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 goal of this clinical research study is to learn how often using a positron emission tomography-computed tomography (PET-CT) scan in addition to a standard computed tomography (CT) scan will change the surgical plan in patients with metastatic melanoma.
Detailed description
If you agree to take part in this study, you will have a PET-CT scan performed. The picture produced by this scan will be compared to a standard CT scan to see if any additional tumors can be located. If the study doctor thinks that additional tumors are present, a biopsy may need to be performed to check the status of the tumors. The type of biopsy will depend on where the tumor(s) are located on the body. If a biopsy is performed, you will sign a separate consent.
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. Women who are unsure if they may be pregnant or think that they may be pregnant must have a negative blood (about 1 teaspoon) pregnancy test.
PET-CT Scan Procedure:
Before the PET-CT scan is performed, you will be asked to avoid stressful exercise for 24 hours. Starting about 12 hours before the scan, you should eat a high protein diet and limit the amount of carbohydrates you eat. Starting about 6 hours before the scan, you should not eat or drink anything other than water (fast) until after the scan is done. You may continue to take prescribed drugs with water during the fasting period.
On the day of the PET-CT scan, you should wear comfortable clothing, preferably without metal buttons and/or zippers. You will be asked to remove any metallic objects you have when you arrive at the PET-CT Center.
- Blood (a few drops from the fingertip) will be collected to check your blood sugar levels.
- A radioactive sugar solution, called fluorodeoxyglucose (FDG), will be given through a needle in a vein of your arm. The injection will last about 5 minutes. Following the FDG injection, you will rest for about 1 hour to allow the FDG to move throughout the body. You will then be asked to urinate before the scan is performed.
You will lie flat on your back on the scanner table. The table will move slowly in and out of a donut-shaped machine called the PET-CT scanner. This scanner creates a picture that shows the FDG in the tumor(s) and organs. The scan takes about 45-60 minutes. You will need to lie as still as possible while the scan is being performed.
Length of Study:
Your participation on this study will be over after PET-CT scan has been completed.
Follow-Up Visits:
As a part of your standard of care, your primary care physician may order additional imaging after your completion of this study for follow-up purposes. The study doctor will review these images 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. The PET-CT component of this study is investigational because it is being done within a certain timeframe (within 30 days after your CT scan) instead of at the timeframe your doctor would normally decide.
Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson Cancer Center (MDACC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-CT Scan | – | Procedure: PET-CT Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals over 18 years of age with metastatic melanoma (melanoma that has spread to other parts of the body) and are considered a candidate for surgery based on a contrast-enhanced computer tomography (CT) scan.
Key inclusion criteria (3 listed)
- AJCC Stage III melanoma with clinically evident (macroscopic) disease, either by physical examination or on conventional imaging, or AJCC stage IV melanoma with metastatic site(s) considered surgically resectable. The initial decision regarding surgical candidacy should be made by surgical oncologist. Patients with indeterminate CT findings that are larger than 1 cm outside of the field of the potential surgery will be also included.
- Contrast- enhanced CT of chest, abdomen and pelvis performed either at MDACC or outside of the institution should indicate surgical candidacy. Outside CT imaging studies should be of acceptable quality, as determined by the evaluating radiologist. PET-CT per protocol must be performed within 30 days from the contrast-enhanced CT.
- 3. Age >/= 18. All minor patients will be excluded to avoid excessive radiation dose. There is data suggesting small but statistically significant increased risk for secondary malignancy due to the cumulative dose of radiation exposure associated with diagnostic imaging. Children are most sensitive to radiation long term adverse effects. Therefore current pilot study will accrue adults only. If the result of this study will indicate potential advantage of PET-CT, this data can be weighted against radiation exposure risks to decide upon imaging strategies in pediatric patients with melanoma.
Key exclusion criteria (2 listed)
- Regional disease limited to an involved sentinel lymph node (occult or microscopic regional nodal metastasis).
- Availability of prior PET-CT, performed within 60 days of initial clinical appointment.
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 |
|---|---|---|
| PET-CT ScanAlso: PET-CTPositron emission tomography-computed tomography (PET-CT) scan performed within 30 days of contrast-enhanced CT. | Procedure or surgery | PET-CT Scan |
Primary outcome
Percent of patients in whom a change in surgical plan occurred based on PET-CT result
Time frame: Evaluation following PET-CT performed within 30 days of contrast-enhanced CT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Yulia Bronstein, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 28 Mar 2012. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients in whom a change in surgical plan occurred based on PET-CT result (time frame: Evaluation following PET-CT performed within 30 days of contrast-enhanced CT.). 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 28 Mar 2012.