PET-MRI After Radiofrequency Ablation (RFA) or Microwave Ablation (MWA)

NCT01895673 | Completed DMC

• 1 other identifier: NL43058.000.13
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the ability of PET-MRI and to detect a local site recurrence during the first year of follow-up after RFA or MWA of colorectal liver metastases (CRLM) as compared with contrast enhanced (ce) CT and PET-CT. Standard reference will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with histology (when available) or clinical follow-up. Secondary outcomes are the inter-observer variability, the ability to diagnose new intrahepatic lesions and in what way PET-MRI is able to influence future treatment compared to PET-CT and ceCT. The patients satisfaction concerning the PET-MRI will be examined with a questionnaire.

Conditions

Liver Neoplasms; Local Neoplasm Recurrence

Keywords

FDG-PET; Radiofrequency Ablation; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Local site recurrence (LSR) detection

  The primary objective of this study is to evaluate the ability of PET-MRI and diffusion and contrast enhanced MRI to detect LSR during the first year of follow-up after RFA treatment of CRLM as compared with ceCT and PET-CT. Standard reference will be clear focal uptake in the rim of the lesion on PET-CT, possibly in combination with histology (when available) or clinical follow-up.

  1 year

Secondary Outcomes (4)

• Detection new intrahepatic lesions

  1 year

• inter-observer variability

  1 year

• Influence on decision making

  1 year

• Patients experience with PET-CT and PET-MRI

  end of one year follow-up

Study Arms (1)

PET-MRI

Twenty patients with RFA/MWA for CRLM or RFA/MWA of recurrent liver lesions after prior local treatment of CRLM and are eligible to undergo MRI-scanning are included when they have adequate renal function. Patients that do not meet inclusion criteria for undergoing an MRI scan are excluded.

Other: Gadolinium

Interventions

Gadolinium OTHER

All patients will undergo PET-MRI additional to the PET-CT they routinely undergo. All patients will be administered Gadolinium for the PET-MRI scan. This is an extra intervention than they would normally undergo.

PET-MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Twenty patients with primary CRLM or recurrent liver disease after prior local treatment of CRLM that have been treated with RFA or MWA and are eligible to undergo MRI-scanning are included when they have adequate renal function. Patients that do not meet inclusion criteria for undergoing an MRI scan are excluded. Patients are recruted by the study coordinators (K Nielsen or HJ Scheffer) when meeting in- and exclusion criteria from the VU Univeristy medical centre and the Gelderse Vallei hospital in Ede. All scans will be made in the VU University medical centre.

You may qualify if:

• Histological or cytological documentation of primary colorectal tumor
• Radiological or histological prove of one or more CRLM or radiological proof of a LSR after previous RFA/MWA treatment for CRLM
• CRLM or LSR treated with RFA/MWA or RFA/MWA in combination with resection
• Follow-up imaging performed in Free University (VU) University Medical Center
• Age ³ 18 years
• Life expectancy of at least 1 year
• estimated glomerular filtration rate (eGFR) \> 60 or hydration according to protocol before scanning
• Written informed consent.

You may not qualify if:

• cirrhosis or steatosis of the liver
• Chemotherapy ≤ 6 weeks before scanning (during the entire study)
• Pregnant or breast-feeding subjects
• Allergy to contrast media
• Patients developing recurrent intrahepatic disease that require resection of the ablated lesion
• eGFR \< 60, unless hydration according to protocol is possible
• claustrophobia
• intracranial clips
• any implanted stimulation device (eg. internal cardioverter defibrillator/pacemaker, cochlear implant)
• intra-ocular metal splinters or metal clips
• Metal artificial heart valve
• Bone prosthesis \< 6 weeks
• inability to lie still for 30 minutes
• orthopnea
• intestinal video capsule

Sponsors & Collaborators

• dr. M.P. van den Tol MD PhD: lead

Study Sites (1)

VU University Medical Centre

Amsterdam, North Holland, 1081 hv, Netherlands

Location

Related Publications (1)

• Nielsen K, Scheffer HJ, Pieters IC, van Tilborg AA, van Waesberghe JH, Oprea-Lager DE, Meijerink MR, Kazemier G, Hoekstra OS, Schreurs HW, Sietses C, Meijer S, Comans EF, van den Tol PM. The use of PET-MRI in the follow-up after radiofrequency- and microwave ablation of colorectal liver metastases. BMC Med Imaging. 2014 Aug 8;14:27. doi: 10.1186/1471-2342-14-27.

  PMID: 25103913 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Recurrence, Local

Interventions

Gadolinium

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Petrousja van den Tol, MD PhD

  VU University Medical Centre

  PRINCIPAL INVESTIGATOR

• Indra C Pieters, MD PhD

  VU University Medical Centre

  PRINCIPAL INVESTIGATOR

• Emile FI Comans, MD PhD

  VU University Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: July 10, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

NL (1)