11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)

NCT02519049 | Completed

• 1 other identifier: 1287
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to pleurodesis.

Conditions

Mesothelioma, Malignant

Keywords

Mesothelioma; 11C-methionine PET; talc pleurodesis

Outcome Measures

Primary Outcomes (1)

• Variation of SUVmax (Maximal Standardized Uptake Value) in patients undergoing talc pleurodesis

  Change from Baseline in SUVmax up to 1 week after talc pleurodesis.

Interventions

No intervention OTHER

This is an observational study

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

All patients affected by MPM and referred to our Institution for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. A minimum number of 20 patients will be considered for the analysis.

You may qualify if:

• patients with an histological diagnosis of MPM eligible for pleurodesis and scheduled to undergo platinum- and pemetrexed-based chemotherapy.
• obtained informed consent

You may not qualify if:

• patients age \<18 years
• pregnancy or breast-feeding;
• patients affected by other malignancies within the last 3 years;

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (6)

• Lopci E, Zucali PA, Ceresoli GL, Perrino M, Giordano L, Gianoncelli L, Lorenzi E, Gemelli M, Santoro A, Chiti A. Quantitative analyses at baseline and interim PET evaluation for response assessment and outcome definition in patients with malignant pleural mesothelioma. Eur J Nucl Med Mol Imaging. 2015 Apr;42(5):667-75. doi: 10.1007/s00259-014-2960-y. Epub 2014 Nov 18.

  PMID: 25403555 BACKGROUND

• Ceresoli GL, Chiti A, Zucali PA, Cappuzzo F, De Vincenzo F, Cavina R, Rodari M, Poretti D, Lutman FR, Santoro A. Assessment of tumor response in malignant pleural mesothelioma. Cancer Treat Rev. 2007 Oct;33(6):533-41. doi: 10.1016/j.ctrv.2007.07.012. Epub 2007 Aug 30.

  PMID: 17764849 BACKGROUND

• Ceresoli GL, Chiti A, Santoro A. 11C-labeled methionine and evaluation of malignant pleural mesothelioma. N Engl J Med. 2007 Nov 8;357(19):1982-4. doi: 10.1056/NEJMc071823. No abstract available.

  PMID: 17989397 BACKGROUND

• Lopci E, Novellis P, Testori A, Rahal D, Voulaz E, Bottoni E, Ferraroli GM, Crepaldi A, Ceresoli GL, Perrino M, Castello A, Alloisio M, Veronesi G, Zucali PA. In-vivo imaging of methionine metabolism in patients with suspected malignant pleural mesothelioma. Nucl Med Commun. 2019 Nov;40(11):1179-1186. doi: 10.1097/MNM.0000000000001078.

  PMID: 31568271 BACKGROUND

• Zucali PA, Lopci E, Ceresoli GL, Giordano L, Perrino M, Ciocia G, Gianoncelli L, Lorenzi E, Simonelli M, De Vincenzo F, Setti LR, Bonifacio C, Bonomi M, Bombardieri E, Chiti A, Santoro A. Prognostic and predictive role of [18 F]fluorodeoxyglucose positron emission tomography (FDG-PET) in patients with unresectable malignant pleural mesothelioma (MPM) treated with up-front pemetrexed-based chemotherapy. Cancer Med. 2017 Oct;6(10):2287-2296. doi: 10.1002/cam4.1182. Epub 2017 Sep 21.

  PMID: 28941158 BACKGROUND

• Bonomi M, De Filippis C, Lopci E, Gianoncelli L, Rizzardi G, Cerchiaro E, Bortolotti L, Zanello A, Ceresoli GL. Clinical staging of malignant pleural mesothelioma: current perspectives. Lung Cancer (Auckl). 2017 Aug 18;8:127-139. doi: 10.2147/LCTT.S102113. eCollection 2017.

  PMID: 28860886 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biopsy specimen

MeSH Terms

Conditions

Mesothelioma, Malignant; Mesothelioma

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Egesta Lopci, MD

  Humanitas Clinical and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: August 10, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

IT (1)