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Trial registered on ANZCTR


Registration number
ACTRN12621000671864
Ethics application status
Approved
Date submitted
1/04/2021
Date registered
2/06/2021
Date last updated
22/06/2025
Date data sharing statement initially provided
2/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of tumour cell death with 68Ga Cell Death Indicator Positron Emission Tomography (CDI-DX001 PET): Proof of Concept
Scientific title
Assessment of tumour cell death with 68Ga Cell Death Indicator Positron Emission Tomography (CDI-DX001 PET): Proof of Concept study in breast cancer, oesophageal cancer, colorectal cancer and non Hodgkin's lymphoma patients
Secondary ID [1] 304104 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 321437 0
Oesophageal cancer 321438 0
Colorectal cancer 321439 0
Lymphoma 321440 0
Condition category
Condition code
Cancer 319197 319197 0 0
Breast
Cancer 319198 319198 0 0
Oesophageal (gullet)
Cancer 319199 319199 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 319200 319200 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be intravenously administered 1.8-2.2MBq/kg (maximum 220MBq) of [68Ga]gallium 2,2'-(7-(4-((1-carboxy-4-((1-((carboxymethyl)amino)-3-((2-((4-(dihydroxyarsaneyl)phenyl)amino)-2-oxoethyl)thio)-1-oxopropan-2-yl)amino)-4-oxobutyl)amino)-1-carboxylato-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetate (68Ga Cell Death Indicator [CDI-DX001]) on two occasions, once within 14 days prior to commencing treatment and the second between day 3-8 or 15-20 (inclusive) after commencement of treatment (systemic therapy +/- radiotherapy in the case of oesophageal / gastro-oesophageal and colorectal carcinoma; systemic therapy in the case of breast carcinoma; and, chemotherapy in the case of lymphoma).

One hour following each CDI-DX001 administration, participants will undergo a positron emission tomography (PET) scan where they will lie still on a scanning bed (breathing normally). The scan will take approximately 30 minutes.

CDI-DX001 will be administered by a nuclear medicine specialist or medical radiation scientist. CDI-DX001 administration and PET scanning will occur at the Prince of Wales Hospital (Randwick, NSW), St George Hospital (Kogarah, NSW), St. Vincent's Hospital (Darlinghurst, NSW), Concord Hospital (Concord, NSW), and Westmead Hospital (Westmead, NSW).
Intervention code [1] 320172 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327068 0
Assessment of tumour uptake of CDI-DX001 at baseline and following treatment.
Timepoint [1] 327068 0
Tumour uptake of CDI-DX001 assessed on PET scan performed within 14 days prior to commencement of treatment and then again between days 3-8 or 15-20 after commencing treatment.
Secondary outcome [1] 393665 0
Histopathological response for oesophageal/ gastro-oesophageal and colorectal carcinoma assessed on the resected surgical specimen following completion of neoadjuvant systemic therapy.
Timepoint [1] 393665 0
Assessed once following surgical resection of the oesophageal / gastro-oesophageal and colorectal carcinoma (resection usually occurs 3-6 months following commencement of neoadjuvant systemic therapy, depending on the treatment regime).
Secondary outcome [2] 393666 0
Histopathological response for breast carcinoma assessed on the resected surgical specimen following completion of neoadjuvant therapy.
Timepoint [2] 393666 0
Assessed once following surgical resection of the breast carcinoma (resection usually occurs 3-6 months following commmencement of neoadjuvant therapy, depending on the treatment regime).
Secondary outcome [3] 393667 0
Imaging response for Non-Hodgkin's Lymphoma assessed with a fluoro-deoxyglucose (FDG) PET scan.
Timepoint [3] 393667 0
Assessed once using an FDG PET scan performed following completion of systemic therapy (5-6 months after commencement of treatment depending on the regime used)
Secondary outcome [4] 393668 0
Uptake of CDI-DX001 in normal tissues assessed on PET scan.
Timepoint [4] 393668 0
Normal tissue uptake of CDI-DX001 assessed twice on PET scan performed within 14 days prior to commencement of treatment and then again between days 3-8 or 15-20 after commencing treatment.
Secondary outcome [5] 394885 0
Safety and tolerability of CDI-DX001 will be assessed by participant reported symptoms and clinical assessment.
Timepoint [5] 394885 0
Safety and tolerability of CDI-DX001 will be assessed once after completion of the PET scan performed within 14 days prior to commencement of treatment and then after completion of the PET scan between days 3-8 or 15-20 after commencing treatment,
Secondary outcome [6] 448916 0
Clinical outcomes at 12 months for participants with refractory, recurrent, or metastatic disease where surgical resection is not undertaken.
Timepoint [6] 448916 0
Assessed at 12 months following the commencement of standard of care cancer treatment.

Eligibility
Key inclusion criteria
General
Male or female patients greater than or equal to 18 years of age
Histologically or cytologically confirmed
• Oesophageal / gastro-oesophageal junction (GOJ) carcinoma or colorectal carcinoma OR
• Breast carcinoma OR
• Diffuse large B cell lymphoma (DLBCL) or follicular large B cell lymphoma (FLBCL)
At least one measurable lesion greater than or equal to 2 cm in maximum transaxial dimension. Adequate renal function (eGFR >30 ml/min/1.73m2).

Additional inclusion criteria for oesophageal / GOJ carcinoma and colorectal carcinoma:
Newly diagnosed, refractory, recurrent or metastatic oesophageal / GOJ or colorectal carcinoma planned for systemic therapy +/- radiotherapy.

Additional inclusion criteria for breast carcinoma:
Newly diagnosed, refractory, recurrent or metastatic breast carcinoma planned for systemic therapy. If HER2 positive eligible to receive trastuzumab as part of neoadjuvant systemic treatment.

Additional inclusion criteria for DLBCL or FLBCL:
Newly diagnosed or refractory / relapsed DLBCL or FLBCL planned for treatment with combination chemotherapy with curative intent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cancer treatment within the previous 6 weeks
Active uncontrolled infection
Congestive heart failure or prior NYHA class III-IV cardiac disease
Uncontrolled hypertension (systolic BP > 180mmHg or diastolic BP >100mmHg)
Pregnancy
Breast feeding

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The statistical analysis of the CDI-DX001 PET scans will assess tumour and normal tissue SUVmax, SUVmean before and following commencement of treatment as well as the change between pre-treatment and following commencement of treatment.

To determine if there is a significant change in the mean values pre-treatment and following commencement of treatment for tumour and normal tissues a paired t-test will be used.

To further determine the clinical significance of absolute and change in CDI uptake, correlation with subsequent clinical outcome will be undertaken. For oesophageal/GOJ adenocarcinoma, colorectal adenocarcinoma and breast carcinoma, pathological response on the surgical specimen will be used as the reference, and for DLBCL and FLBCL the Deauville score of end of treatment FDG PET CT will be used as the reference standard.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/03/2022
Actual
4/04/2022
Date of last participant enrolment
Anticipated
29/08/2025
Actual
Date of last data collection
Anticipated
28/08/2026
Actual
Sample size
Target
36
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19053 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 26593 0
St George Hospital - Kogarah
Recruitment hospital [3] 26594 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [4] 28130 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 33601 0
2031 - Randwick
Recruitment postcode(s) [2] 42636 0
2217 - Kogarah
Recruitment postcode(s) [3] 42637 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 44336 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 319265 0
Government body
Name [1] 319265 0
Cancer Institute of NSW
Country [1] 319265 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney Local Health District
Address
Research Support Office
G71 East Wing Edmund Blacket Building
Prince of Wales Hospital
Barker Rd, Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 309054 0
None
Name [1] 309054 0
Address [1] 309054 0
Country [1] 309054 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308240 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 308240 0
Ethics committee country [1] 308240 0
Australia
Date submitted for ethics approval [1] 308240 0
06/04/2021
Approval date [1] 308240 0
12/05/2021
Ethics approval number [1] 308240 0
2021ETH00323

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110034 0
A/Prof Ivan Ho Shon
Address 110034 0
Department of Nuclear Medicine and PET Level 2, Campus Centre Prince of Wales Hospital Barker St, Randwick, NSW 2031, Australia
Country 110034 0
Australia
Phone 110034 0
+61 2 93822239
Fax 110034 0
+61 2 93822235
Email 110034 0
[email protected]
Contact person for public queries
Name 110035 0
Ivan Ho Shon
Address 110035 0
Department of Nuclear Medicine and PET Level 2, Campus Centre Prince of Wales Hospital Barker St, Randwick, NSW 2031, Australia
Country 110035 0
Australia
Phone 110035 0
+61 2 93822200
Fax 110035 0
+61 2 93822235
Email 110035 0
[email protected]
Contact person for scientific queries
Name 110036 0
Ivan Ho Shon
Address 110036 0
Department of Nuclear Medicine and PET Level 2, Campus Centre Prince of Wales Hospital Barker St, Randwick, NSW 2031, Australia
Country 110036 0
Australia
Phone 110036 0
+61 2 93822200
Fax 110036 0
+61 2 93822235
Email 110036 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.