PET/CT Imaging for Breast Cancer

(ISO-1Primary Trial)

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Imaging intolerance, Serious conditions, others

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

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is 18F-ISO-1 PET/CT imaging safe for humans?

The first study in humans evaluated the safety of 18F-ISO-1 and found it feasible for imaging tumor proliferation, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How is PET/CT imaging unique for breast cancer treatment?

PET/CT imaging for breast cancer is unique because it uses a special type of scan that combines positron emission tomography (PET) and computed tomography (CT) to visualize the primary tumor and detect cancer spread. This method is particularly useful for staging breast cancer and assessing the response to chemotherapy, offering detailed insights into the biological characteristics of the cancer. ^{1 2 6 7 8}

What is the purpose of this trial?

This trial uses a new imaging method to detect specific features in breast cancer cells. It targets patients with primary breast cancer to see how well this method works and to ensure it is safe. The imaging substance helps make the cancer cells visible.

Research Team

Elizabeth McDonald, MD

Principal Investigator

University of Pennsylvania

David Mankoff, MD, PHD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 with known or suspected breast cancer and at least one lesion larger than 1 cm. They must understand the study's experimental nature and give written consent. It excludes pregnant women, those unable to undergo imaging procedures, and individuals with serious medical or psychological conditions.

Inclusion Criteria

Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures

I have a breast lesion that is at least 1 cm big, confirmed by imaging.

Exclusion Criteria

Unwilling or unable to provide informed consent.

Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening

Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive an [18F]ISO-1 PET/CT scan to evaluate sigma-2 receptor activity in primary breast cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

6 years

Treatment Details

Interventions

• [18F]ISO-1

Trial Overview [18F]ISO-1 PET/CT scans are being tested to see how well they can detect sigma-2 receptor activity in primary breast cancer sites. This could help in assessing the tumor's characteristics using a new type of imaging tracer.

Participant Groups

Group I: ISO-1 PET/CT Experimental Treatment 1 Intervention

All subjects will receive an \[18F\]ISO-1 PET/CT scan

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Findings from Research

Positron emission tomography (PET) is becoming an important tool in both the clinical management and research of breast cancer, helping to visualize and understand the disease better.

Current applications primarily use the radiotracer (18)F-fluorodeoxyglucose (FDG), but there is ongoing research into other radiopharmaceuticals that could provide more insights into breast cancer biology and may soon be tested in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future use of positron emission tomography (PET) in breast cancer. Mankoff, DA., Eubank, WB.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Accuracy of 18F-FDG PET/CT for primary tumor visualization and staging in T1 breast cancer. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Imaging in breast cancer: Single-photon computed tomography and positron-emission tomography. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer 18F-ISO-1 Uptake as a Marker of Proliferation Status. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

PET/Computed Tomography in Breast Cancer: Can It Aid in Developing a Personalized Treatment Design? [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Assessment of cellular proliferation in tumors by PET using 18F-ISO-1. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Nuclear medicine in primary breast cancer imaging. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The preliminary study of 16α-[18F]fluoroestradiol PET/CT in assisting the individualized treatment decisions of breast cancer patients. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Current and future use of positron emission tomography (PET) in breast cancer. [2018]