None listed
Conditions
Brief summary
68Ga-Cell Death Indicator PET (CDI-DX001 PET) is a new technique that has been developed to directly image dead and dying tumour cells in patients using a PET scan. This study aims to assess if CDI-DX001 PET can detect an increase in dead and dying tumour cells following commencement of treatment in cancer patients. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been newly diagnosed with oesophageal cancer, or gastro oesophageal junction (GOJ) adenocarcinoma, or colorectal cancer, or breast cancer, or diffuse large B-cell lymphoma (DLBCL) or follicular large B cell lymphoma (FLBCL), and you are scheduled for preoperative systemic therapy or combination chemotherapy to treat your cancer. Study details Participants who choose to enrol in this study will be injected with a small dose of CDI-DX001. They will undergo two PET imaging scans (during which they will be required to lie still on a scanning bed breathing normally) - The first dose and PET scan will be scheduled for within 14 days before starting cancer treatment, and the second dose and PET scan will be scheduled between days 3-8 or 15-20 days after commencement of cancer treatment. The results of the scans will also be compared to other test results provided by their doctor including results of subsequent surgery and imaging. It is hoped this research may be used to improve health outcomes for future cancer patients by investigating the usefulness and safety of a new imaging technique which images dead and dying cancer cells as a way of potentially more rapidly and accurately assessing cancer treatment response than currently available methods.
Interventions
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 treatm
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).
Sponsors
South Eastern Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed