NCT03116412

A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma

A Prospective Randomized Multicenter Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of Stage IIb-c and III Cutaneous Malignant Melanoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,300 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.

Detailed description

The patients are randomized 1:1 to routine follow up for 3 years with regular doctors´ appointments according to national guidelines and the same follow up but with the addition of whole body CT or Positron Emission Tomography (PET) scans and blood tests. An interim analysis will be conducted when 1000 patients have been included.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
PROCEDURE	CT or PET scans	Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.

Timeline

• Start date: 2017-06-08
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2017-04-17
• Last updated: 2024-12-16

Locations

20 sites across 1 country: Sweden