We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Whole-body DW-MRI and cfDNA Analysis for the Surveillance of Melanoma Patients at High Risk for Recurrence. (DW-MRi)

This study is currently recruiting participants.
Verified August 2016 by Universitair Ziekenhuis Brussel
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907827
First Posted: September 20, 2016
Last Update Posted: May 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel
  Purpose
Patients with locally advanced melanoma are at high risk for recurrence following surgical treatment. More patients with stage IV melanoma remain in complete remission following systemic therapy. No standards have been established for the surveillance of patients at high risk for recurrence. Whole-body diffusion-weighted magnetic resonance imaging and cfDNA analysis of blood are innovative imaging and laboratory investigations that may be of benefit for early detection of recurrence in this patient population.

Condition Intervention
Melanoma Other: follow up DW MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Whole-body Diffusion-weighted Magnetic Resonance Imaging and cfDNA Analysis for the Surveillance of Melanoma Patients at High Risk for Recurrence Following Surgery or Systemic Therapy

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • explorative evaluation of the use of DWMRI in the follow-up of high risk melanoma patients [ Time Frame: 5years ]

Secondary Outcome Measures:
  • • Distant metastasis-free survival (for stage III patients only), overall survival [ Time Frame: 5years ]
  • • Registration of the nature and result of salvage therapies offered at the time of detection of recurrence/progression [ Time Frame: 5 years ]
  • • Explore the correlation of cfDNA measurements and the clinical or MRI based diagnosis of recurrence/progression [ Time Frame: 5years ]

Estimated Enrollment: 100
Study Start Date: November 2014
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stage IV melanoma CR>3years
Stage IV: Complete remission for more than 3 years, confirmed by most recent CT or PET-CT imaging
Other: follow up DW MRI
Whole-body diffusion-weighted magnetic resonance imaging and cfDNA analysis
Other Name: cfDNA
Experimental: Stage III Melanoma
AJCC Stage III: No evidence of disease on most recent CT or PET-CT imaging
Other: follow up DW MRI
Whole-body diffusion-weighted magnetic resonance imaging and cfDNA analysis
Other Name: cfDNA

Detailed Description:

Cutaneous melanoma is the most aggressive form of skin cancer. Melanoma is the malignant cancer that originates from the melanocytes of the body (= pigmented cells of the body). Melanoma can originate from the melanocytes that are present in the skin, mucosa, or the uvea of the eye.

The incidence of melanoma is continuing to rise at a rate exceeding all other cancers. Every year approximately 132,000 and 1,000 people will be diagnosed with melanoma and 37,000 and 250 people are expected to die of the disease respectively worldwide and in Belgium. Surgical resection is curative for most cases of early identified and localized melanoma (90% long term survival for stage I disease) . Patients with stage II/III disease are at high risk of relapse after surgery, even when followed by radiotherapy and adjuvant IFN alfa-2b therapy (the risk of recurrence for these patients is 60% to 75%).

In 2010 Romano et al. published a study evaluating the time to relapse and the site of relapse in 340 patients (Figure 1: relapse free survival of all 340 patients with substages IIIA,IIIB and IIIc). Patients and/or family members discovered 62% of local and in-transit recurrences and 49% of nodal recurrences. Only 37% of patients whose first recurrence was systemic detected the recurrence themselves, either by noticing a new tumor or other symptoms that led to further evaluation. Physical examination by a physician accounted for the detection of 36% of the local and in-transit recurrences, Twenty-six percent of nodal recurrences were detected by physicians however only in 9% systemic recurrences did they discover systemic recurrence. In the remaining 63% of patients whose first detectable relapse was systemic, the relapse was asymptomatic. Radiographic tests, largely CT scans (72%), detected asymptomatic systemic relapses in 53% (n_87) of these patients. This study also demonstrated the benefit of identifying early relaps, since symptomatic relapses, as opposed to relapses discovered by physical examination or radiographic imaging, were associated with shorter survival. And confirming that a recurrence that could be completely resected was associated with longer survival (relative risk_2.31; 95% CI, 1.68 to 3.18; P_.001).

In the last several years the therapeutic landscape of melanoma has changed. The introduction of immunotherapy has increased the life expectancy for melanoma stage IV patients and even has the possibility for cure of the disease. This changes the need in screening. Since no therapeutic options were available, there was no need for a strict follow-up. The primary objective of follow-up in these patients with melanoma was to identify potentially curable locoregional recurrences and second primary cancers. Optimal follow-up strategies and intervals have not been determined, and there is no consensus. At a minimum, patients should undergo an annual routine physical examination, including a full skin assessment and palpation of the regional lymph nodes. The role of imaging in the follow-up of high risk patients is not clear. Since the introduction of newer therapies, the need for a more closer follow-up has emerged as well.

The outcome of patients with stage IV disease is grim with less than 50% of patients surviving for more than 12 months. Short-lived tumor responses are obtained in about 10-20% of patients treated with DTIC chemotherapy but no randomized trial could demonstrate a survival benefit for more complex chemotherapy regimens or so-called bio-chemotherapy regimens despite higher response rates.

In march 2011 a CTLA-4 inhibitor, Ipilimumab (Yervoy), was aproved by the FDA. It was the first treatment to prove a survival benefit in melanoma patients. An interesting aspect about the treatment with Ipilimumab is the plateau seen after 2 years.This plateau represents patient with a long term survival benefit of Ipilimumab and even the possibility of 'cure'. The patients in this population now undergo repeated imaging with PET CT and/or CT. This leads to a high radiation burden for this patients. The DW-MRI could in this population have a benefit.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Histologically confirmed malignant melanoma;
  • AJCC Stage III: No evidence of disease on most recent CT or PET-CT imaging
  • Stage IV: Complete remission for more than 3 years, confirmed by most recent CT or PET-CT imaging

Exclusion Criteria:

  • Contra-indication for MRI: pacemaker, metallic foreign body in eye, recent operation with prosthetic material (< 6weken)
  • Claustrophobia
  • Metallic devices implanted such as hip prostheses, since this can alter the imaging quality
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907827


Contacts
Contact: Bart Neyns, MD Phd 02 477 60 40 bart.neyns@uzbrussel.be
Contact: Yanina JL Jansen, MD 02 477 91 23 yanina.jansen@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Jette, Brabant, Belgium, 1090
Contact: Bart Neyns, Phd,Md    0032(0)2477 64 15    bart.neyns@uzbrussel.be   
Principal Investigator: Bart Neyns, Phd,Md         
UZ Brussel Recruiting
Laken, Brussels, Belgium, 1090
Contact: Katrien Vandenbossche, study nurse    0032 2 477 54 47    katrien.vandenbossche@uzbrussel.be   
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Bart Neyns, Md Phd Universitair Ziekenhuis Brussel
  More Information

Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02907827     History of Changes
Other Study ID Numbers: 2014-BN-002
First Submitted: September 14, 2016
First Posted: September 20, 2016
Last Update Posted: May 25, 2017
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: anonymous

Keywords provided by Universitair Ziekenhuis Brussel:
complete remission
cfDNA
DW-MRI
surveillance

Additional relevant MeSH terms:
Melanoma
Recurrence
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Disease Attributes
Pathologic Processes