A Randomized Trial to Assess the Role of Imaging During Follow Up After Radical Surgery of High Risk Melanoma
Recruiting · NCT03116412 · Interventional (participants receive a specific treatment) · Lead sponsor: Uppsala University
View the official record on ClinicalTrials.gov →Interventions studied
CT or PET scans
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- At least 18 years of age.
- Radical surgery for Cutaneous Malignant Melanoma (CMM) stage IIb-c and III.
- Sufficient renal function for i.v. contrast scannings.
Exclusion criteria
- The patient is assessed as unfit to receive treatment in the case of recurrence.
- Life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis).
- Inability to provide informed consent or refusal to do so.
- Inability to comply with the control or intense follow-up program.
- Participation in other clinical trials interfering with the control-program.
- Existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer).
- Pregnancy or currently planned pregnancy.
Where it is running
20 locations listed.
- Södra Älvsborgs sjukhus - Borås, Sweden
- Mälarsjukhuset Eskilstuna - Eskilstuna, Sweden
- Falu lasarett - Falun, Sweden
- Department of Surgery, Sahlgrenska University Hospital - Gothenburg, Sweden
- Gävle sjukhus - Gävle, Sweden
- Helsingborgs lasarett - Helsingborg, Sweden
- Länssjukhuset Ryhov - Jönköping, Sweden
- Länssjukhuset i Kalmar - Kalmar, Sweden
- Centralsjukhuset i Karlstad - Karlstad, Sweden
- Linköping University Hospital - Linköping, Sweden
- Skåne University Hospital - Malmö, Sweden
- Skaraborgs sjukhus Skövde - Skövde, Sweden
- Karolinska University Hospital - Stockholm, Sweden
- Länssjukhuset Sundsvall - Sundsvall, Sweden
- Uddevalla sjukhus - Uddevalla, Sweden
- Umeå University Hospital - Umeå, Sweden
- Akademiska sjukhuset - Uppsala, Sweden
- Visby lasarett - Visby, Sweden
- Västmanlands sjukhus Västerås - Västerås, Sweden
- Örebro University Hospital - Örebro, Sweden