NCT00828126

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

3.2 years

First QC Date

January 13, 2009

Last Update Submit

March 26, 2012

Conditions

Melanoma

Keywords

Metastatic MelanomaAJCC Stage III MelanomaAJCC stage IV MelanomaPET-CTPositron Emission Tomography-Computed TomographyContrast-enhanced Computed Tomography ScanCTConventional ImagingFalse Positive RateFluorodeoxyglucoseFDGSurgery

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (1)

PET-CT Scan

Procedure: PET-CT Scan

Interventions

PET-CT ScanPROCEDURE

Positron emission tomography-computed tomography (PET-CT) scan performed within 30 days of contrast-enhanced CT.

Also known as: PET-CT
PET-CT Scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yulia Bronstein, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 23, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 28, 2012

Record last verified: 2012-03

Locations

US(1)