Copper Imaging for Pancreatic Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for imaging pancreatic cancer using a special compound called Copper Cu 64-DOTA-A2DM in a PET scan. It targets patients with advanced pancreatic cancer that has spread locally or to other parts of the body. The trial aims to determine if this method safely and effectively provides detailed images of cancer cells. Suitable participants have advanced pancreatic cancer that cannot be surgically removed and have had a recent scan showing cancer spread. As a Phase 1 trial, the research seeks to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative imaging method.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop chemotherapy, radiation therapy, biological therapy, or immunotherapy at least 14 days before starting the study treatment. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

What prior data suggests that this imaging technique is safe for pancreatic cancer patients?

Research has shown that using copper-based compounds like Copper Cu 64-DOTA-A2DM for imaging is generally safe. This compound resembles copper Cu 64 dotatate, which the FDA has approved for imaging certain tumors, indicating a reasonable level of safety for similar compounds in humans.

Copper Cu 64 dotatate has been used successfully, with manageable side effects mainly related to radiation exposure. Although there is always a risk of increased radiation exposure, this is common in most imaging procedures using radioactive materials.

In other studies with copper-based imaging agents, side effects were minimal and mostly related to the procedure itself, not the compound. The safety profile appears favorable, but it is important to remember that all imaging agents contribute to a patient's overall radiation exposure.12345

Why are researchers excited about this trial?

Unlike the standard of care for pancreatic cancer, which often involves chemotherapy and radiation, Copper Cu 64-DOTA-A2DM offers a novel approach by using a radioactive copper isotope. This treatment is unique because it integrates a PET scan to track how the drug targets cancer cells, potentially allowing for more precise imaging and assessment. Researchers are excited about this treatment as it could provide a more accurate diagnosis and evaluation of pancreatic cancer, which is crucial for tailoring more effective treatment plans.

What evidence suggests that this imaging technique is effective for pancreatic cancer?

Research has shown that Copper Cu 64-DOTA-A2DM, which participants in this trial will receive, can help create clear images of certain cancers, such as pancreatic cancer, when used with PET scans. This compound attaches to areas with high concentrations of a specific protein found in these cancer cells. Studies have demonstrated that similar compounds using copper-64 effectively highlight tumors in imaging tests. For instance, copper-64 has successfully visualized neuroendocrine tumors, providing detailed images that aid in diagnosis. This suggests that Copper Cu 64-DOTA-A2DM might also effectively image pancreatic cancer, helping doctors detect the disease more accurately.12678

Who Is on the Research Team?

JY

Jeffrey Y Wong, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for people with pancreatic cancer that has spread locally or to other parts of the body, and whose tumors show PSCA protein. Participants must be able to undergo imaging scans and meet basic health requirements.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative
AST ≤ 3.0 x ULN
Hemoglobin ≥ 9g/dL with no red blood cell transfusions within 14 days of assessment unless cytopenia is disease-related
See 10 more

Exclusion Criteria

Any condition that contraindicates participation due to safety concerns as judged by Investigator
Participants unable to comply with all study procedures including feasibility or logistics issues as judged by Investigator
I am currently pregnant or breastfeeding.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Patients receive unlabeled DOTA-A2DM IV, followed by labeled 64Cu-DOTA-A2DM, and undergo PET scans

2 days
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Copper Cu 64-DOTA-A2DM

Trial Overview

The study tests a new imaging agent called 64Cu-DOTA A2 scFv-Fc2 DM used with PET scans to help visualize pancreatic cancers that express PSCA. The goal is to check its safety, side effects, best dose, and how well it works for imaging.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Other (64Cu-DOTA A2 scFv-Fc2 DM with PET scan)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

64Cu-DOTA A2 scFv-Fc2 DM With Positron Emission ...

Using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography may be a safe and feasible way to obtain diagnostic images of patients with ...

64Cu-DOTA A2 scFv-Fc2 DM With Positron Emission ...

Using 64Cu-DOTA A2 scFv-Fc2 DM with positron emission tomography may be a safe and feasible way to obtain diagnostic images of patients with ...

Molecular Imaging of Cancer with Copper-64 ... - PMC

In this study, 64Cu-DOTA-cetuximab was used to correlate EGFR densities on the surface of 5 different cervical cancer lines with the EGFR messenger RNA (mRNA) ...

“What's New in Imaging: Copper 64 Dotatate vs. GA-Dotatoc ...

“What's New in Imaging: Copper 64 Dotatate vs. GA-Dotatoc PET/CT,” by Dr. Courtney Lawhn Heath. 3.4K views · 2 years ago ...more ...

copper-64 radiopharmaceuticals for receptor

Radiopharmaceuticals which target receptors occurring in much higher numbers on the surface of tumor cells can be used to visualize and/or treat ...

Detectnet (copper Cu 64 dotatate injection), for intravenous use

Handle Detectnet with appropriate safety measures to minimize radiation exposure [see Warnings and. Precautions (5.1)]. Use waterproof gloves, effective ...

Copper-64 Radiopharmaceuticals for PET Imaging of Cancer

This article discusses state-of-the-art cancer imaging with 64 Cu radiopharmaceuticals, including 64 Cu-ATSM for imaging hypoxia, 64 Cu-labeled peptides for ...

Copper cu 64 dotatate (intravenous route) - Side effects & ...

Copper cu 64 dotatate (intravenous route) ... While receiving this medicine, you will be exposed to radiation and increase risk of cancer.