None listed
Conditions
Brief summary
The broad objective of this study is to document and assess the utility of current institutional standard-practice staging procedures for patients with early-stage Merkel cell carcinoma, who are managed at Peter MacCallum Cancer Centre (PMCC) or Liverpool Hospital Who is it for? You may be eligible to join this study if you are aged 18 years or above and have histologically documented cutaneous Merkel cell carcinoma (MCC), stage cT1N0, which is suitable for sentinel lymph node biopsy. Study details Participants in this study undergo standard institutional practice, which involves sentinel lymph node biopsy (SLNB)/ lymphatic mapping and 18F-FDG PET/CT at initial diagnosis. SLNB involves removal and examination of the sentinel node(s) (the first lymph node(s) to which cancer cells are likely to spread from a primary tumor, This involves injection of a radioactive substance, blue dye, or both near the tumor, so that the node can be found using a probe or seen stained with dye. The surgeon then removes the sentinel node(s) to check for the presence of cancer cells. PET/CT scanning involves a small amount of radioactive glucose (sugar) injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. Subsequent treatment of the tumour is undertaken with radiotherapy. Extent of radiotherapy treatment is determined by the results of the SLNB, i.e. if SLNB is negative patients receive treatment to the primary tumour site alone. If the SLNB is positive, patients will undergo treatment to both the primary and (involved) lymph node region. Follow up involves clinical examination at 6 weeks after Radiotherapy, then assessment every 4 months with clinical examination and PET scans as per hospital policy for a minimum of 2 years. Patients with a negative sentinel node will also undergo an ultrasound of the area the lymph node was removed from at each visit. Ultrasound involves a procedure that uses high-energy sound waves to look at tissues and organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen. This study will provide valuable information to guide management for Merkel Cell Carcinoma. There is a lack of information regarding this uncommon, highly aggressive skin cancer.
Interventions
Sponsors
Eligibility
Inclusion criteria
Patients (male or female) above 18 years old Histologically documented cutaneous MCC, stage cT1N0 Suitable for sentinel lymph node biopsy No clinical evidence of regional or distant metastases. Patients must undergo treatment and follow up at Peter MacCallum Cancer Centre, Melbourne or the Liverpool hospital, Sydney.
Exclusion criteria
Proven metastatic disease Patients who refuse radiotherapy Patients who refuse to join the trial or are unable to consent Patients not being considered for further therapy Patients who cannot lie still for at least 30 minutes or comply with imaging Technically unsuitable for for lymphoscintigraphy/ SNB procedure Pregnancy/Lactation