Developing effective imaging methods to assess chemotherapy response in Malignant Pleural Mesothelioma

Apoptosis detection using Technetium 99m labelled Annexin V SPECT/CT imaging to determine chemotherapy response in patients with Malignant Pleural Mesothelioma following initiation of chemotherapy treatment.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12611000266965

Acronym

nil

Enrollment

Registered

2011-03-11

Start date

2012-04-17

Completion date

2013-02-26

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Mesothelioma is an aggressive tumour with a poor outcome and not all patients respond to current best-practice chemotherapy. Response to chemotherapy is currently assessed by measuring tumour size on regular CT scans. Detecting changes in tumour size for Mesothelioma can be difficult due to the growth pattern of the tumour, it grows as a rind around the lining of the chest. Significant changes in 'size' of Mesothelioma on Computerised Tomography (CT) scans may not occur until 2 - 3 months after commencing chemotherapy. The aim of chemotherapy is to cause the tumour cells to die, this process of cell death is called apoptosis. CT scans are able to detect this apoptosis, from chemotherapy treatments, after approximately 3 months. During the past few years, Annexin V has emerged as an agent that can be used to detect cell death. Attaching a radioactive tracer (Technetium -99m), to Annexin V and using a Single Photon Emission Computerised Tomography-CT (SPECT-CT) camera to detect if cell death is occurring one to two days after chemotherapy has started may predict the effectiveness of chemotherapy earlier. This would result in fewer patients continuing ineffective treatment, individualization of chemotherapy treatments, and more rapid and reliable identification of new drugs which may be effective in this disease.

Interventions

Patients will undergo a Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) scan with whole body scintigraphy after administration of a Technicium-labelled Annexin V injection at baseline (2 weeks prior to commencement of chemotherapy) and 48 hours after commencement of chemotherapy. Patients will be injected with an average of 850MBq of 99m Tc-HYNIC-rh-Annexin-V prior to each SPECT/CT scan. Patients will also undergo 18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) scans at baseline (within 2 weeks prior to commencement of chemotherapy) and after the first cycle of chemotherapy (just prior to the second cycle of chemotherapy). Administration of 18F-FDG (200 MBq/m2) will be utilised to assess for response to chemotherapy and patients will be imaged 60 minutes after tracer injection.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histologically confirmed malignant Mesothelioma ECOG performance status 0-2 > 18 years of age Able to undertake SPECT/CT and PET/CT imaging Written informed consent

Exclusion criteria

Pregnancy Age < 18 years Medical contraindication to SPECT/CT or PET/CT imaging. Cognitive impairment considered to impair the ability to give written informed consent in the opinion of the treating clinician.

Outcome results