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

Not Applicable

Recruiting

• Conditions: Breast cancer; Oesophageal cancer; Rectal cancer; Lymphoma; Cancer - Breast; Cancer - Oesophageal (gullet); Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12621000671864
• Lead Sponsor: South Eastern Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-02
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

General
Male or female patients greater than or equal to 18 years of age
Newly diagnosed histologically or cytologically confirmed
•Oesophageal / gastro-oesophageal junction (GOJ) carcinoma or rectal carcinoma OR
•Breast carcinoma OR
•Diffuse large B cell lymphoma (DLBCL) or grade 3 follicular lymphoma (FL)
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 rectal carcinoma
For oesophageal / GOJ carcinoma planned for neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy
For rectal carcinoma, planned for long course neoadjuvant chemoradiotherapy or total neoadjuvant therapy

Additional inclusion criteria for breast carcinoma
For breast carcinoma planned for neoadjuvant chemotherapy
If HER2 positive eligible to receive trastuzumab as part of neoadjuvant systemic treatment

Additional inclusion criteria for DLBCL or grade 3 FL
Planned for treatment with R-CHOP21 or similar

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.]