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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

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Trial Information

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

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

- 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).

Inclusion Criteria:

1. 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.

2. 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. 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

Exclusion Criteria:

1. Regional disease limited to an involved sentinel lymph node (occult or microscopic
regional nodal metastasis).

2. Availability of prior PET-CT, performed within 60 days of initial clinical

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Percent of patients in whom a change in surgical plan occurred based on PET-CT result

Outcome Time Frame:

Evaluation following PET-CT performed within 30 days of contrast-enhanced CT.

Safety Issue:


Principal Investigator

Yulia Bronstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

March 2012

Related Keywords:

  • Melanoma
  • 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
  • Melanoma



UT MD Anderson Cancer Center Houston, Texas  77030