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Assessment of tumour cell death with 68Ga Cell Death Indicator Positron Emission Tomography (68Ga-CDI PET): Proof of Concept

ABSTRACT: 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 [68Ga-CDI]) on two occasions, once within 14 days prior to commencing treatment and the second between day 15 and day 20 (inclusive) after commencement of treatment (chemoradiotherapy in the case of oesophageal / gastro-oesophageal and rectal carcinoma and chemotherapy in the case of breast carcinoma and lymphoma). One hour following each 68Ga-CDI 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. 68Ga-CDI will be administered by a nuclear medicine specialist or medical radiation scientist. 68Ga-CDI administration and PET scannning will occur at the Prince of Wales Hospital, Randwick, NSW. Primary outcome(s): Tumour uptake of 68Ga-CDI assessed on PET scan.[Tumour uptake of 68Ga-CDI assessed on PET scan performed within 14 days prior to commencement of treatment and then again between 15 and 20 days after commencing treatment.] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy

DISEASE(S): Oesophageal Cancer,Cancer-lymphoma (non Hodgkin's Lymphoma)-high Grade Lymphoma,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Rectal Cancer,Cancer-oesophageal (gullet),Breast Cancer,Lymphoma,Cancer-breast

PROVIDER: 2472264 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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