ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12611000266965

Ethics application status

Approved

Date submitted

10/03/2011

Date registered

11/03/2011

Date last updated

12/03/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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.

Secondary ID [1]

nil

Universal Trial Number (UTN)

nil

Trial acronym

nil

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mesothelioma

Condition category

Condition code

Cancer

Lung - Mesothelioma

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

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.

Intervention code [1]

Not applicable

Comparator / control treatment

Routine Computed Tomography (CT) scans will be performed 2 weeks prior to commencement of chemotherapy and after chemotherapy cycle 1.

Control group

Active

Outcomes

Primary outcome [1]

Detection of apoptosis assessed by increased Tc-Annexin activity in tumour using SPECT/CT scan.

Timepoint [1]

48 hours post commencement of chemotherapy.

Secondary outcome [1]

To assess whether the presence of apoptosis following chemotherapy gives preliminary evidence of prediction of clinical benefit from chemotherapy as measured by objective radiological response on CT imaging, FDG PET/CT imaging, time to disease progression and patient survival.

Timepoint [1]

18 months post scans.

Eligibility

Key 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

1/04/2011

Actual

17/04/2012

Date of last participant enrolment

Anticipated

Actual

26/02/2013

Date of last data collection

Anticipated

Actual

1/11/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Sir Charles Gairdner Hospital Research Advisory Committee

Address [1]

Department of Research
Sir Charles Gairdner Hospital
Hospital Ave
NEDLANDS PERTH
Western Australia
6009

Country [1]

Australia

Primary sponsor type

Hospital

Name

Sir Charles Gairdner Hospital

Address

Hospital Avenue
NEDLANDS PERTH
Western Australia
6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sir Charles Gairdner Group Human Research Ethics Committee

Ethics committee address [1]

Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS  PERTH
Western Australia 6009

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/12/2010

Ethics approval number [1]

2010-142

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Roslyn Francis

Address

Department of Nuclear Medicine/ WA PET Service
Sir Charles Gairdner Hospital
Hospital Ave, Nedlands, WA, 6009

Country

Australia

Phone

+61 8 6457 3233

Fax

Ros.Francis@health.wa.gov.au

Contact person for public queries

Name

Elaine Campbell

Address

WA PET Service
Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009

Country

Australia

Phone

+61 8 9346 2322

Fax

+61 8 9346 3610

Elaine.Campbell@health.wa.gov.au

Contact person for scientific queries

Name

Tatiana Segard

Address

WA PET Service / Nuclear Medicine Department
Sir Charles Gairdner Hospital
Hospital Avenue
NEDLANDS, WA 6009

Country

Australia

Phone

+61 8 9346 2322

Fax

+61 8 9346 3610

Tatiana.Segard@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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Documents added manually

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