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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies a new imaging technique to enhance understanding of breast cancer. Researchers use a PET/CT scan with a special tracer called [18F]ISO-1 (a radiotracer) to examine specific receptor activities in breast cancer cells. This technique can provide doctors with insights into breast cancer behavior and potentially improve future diagnosis and treatment. Suitable participants have a known or suspected breast cancer with a lesion (abnormal tissue) 1 cm or larger, as identified in regular imaging tests. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

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.

What prior data suggests that this PET/CT imaging is safe for breast cancer patients?

Research has shown that the experimental tracer [18F]ISO-1, used in PET/CT scans, has been tested in earlier studies for breast cancer. In one study, 28 women with breast tumors underwent [18F]ISO-1 PET/CT scans, and no major side effects occurred. This suggests that [18F]ISO-1 is generally safe. However, as this is a Phase 1 trial, the main goal is to assess the treatment's safety in people. The treatment remains in the early testing stages, and safety information is limited. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]ISO-1 because it offers a new way to visualize breast cancer. Unlike traditional imaging methods, which often use dyes or contrast agents to highlight tumors, [18F]ISO-1 is a radiotracer specifically designed for PET/CT scans. This means it can provide clearer images of the cancer's metabolic activity, potentially making it easier to detect and assess the disease. By targeting specific markers in cancer cells, [18F]ISO-1 could improve the accuracy of diagnoses and help tailor treatments more effectively.

What evidence suggests that this PET/CT imaging is effective for evaluating breast cancer?

Research has shown that a special type of imaging called [18F]ISO-1 PET/CT, which participants in this trial will receive, can help doctors assess activity in breast cancer areas. This imaging uses a substance that highlights where cancer cells are growing. Fast-growing cancer can indicate disease progression. Early studies found that when the body takes up [18F]ISO-1, it correlates with cancer activity. This imaging could help doctors understand tumor aggressiveness and guide treatment choices. While these results are promising, further research is needed to confirm its effectiveness in real-life medical settings. ^{1 3 4 5 6}

Who Is on the Research Team?

Elizabeth McDonald, MD

Principal Investigator

University of Pennsylvania

David Mankoff, MD, PHD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02284919

[18F]ISO-1 Positron Emission Tomography (PET/CT) in ... In this study, positron emission tomography (PET/CT) imaging will be used to evaluate sigma-2 (σ2) receptor activity in sites of primary breast cancer using the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31836680/

Breast Cancer 18F-ISO-1 Uptake as a Marker of Proliferation ... Here, we report the results of the first dedicated clinical trial of 18F-ISO-1 in women with primary breast cancer. Our study objective was to determine whether ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/54/3/350

Assessment of Cellular Proliferation in Tumors by PET Using ... Thus, we have chosen 18F-ISO-1 to study the feasibility of imaging patients with different cancer types including breast, head and neck, and ...

4. aacrjournals.org aacrjournals.org/clincancerres/article/25/10/3063/10762/Cell-Proliferation-Imaging-for-Monitoring-Response

Cell-Proliferation Imaging for Monitoring Response to CDK4/6 ... Our data suggest complementary roles of [18F]FLT and [18F]ISO-1 PET in evaluating tumor-proliferation after combined CDK4/6 inhibitor and endocrine therapy in ...

5. clinicaltrial.be clinicaltrial.be/en/details/11534?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

[18F]ISO-1 Positron Emission Tomography (PET/CT) in ... This study will evaluate the feasibility of using [18F]ISO-1 PET/CT to image sigma-2 receptor binding in primary breast tumors and continue ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7198384/

Breast Cancer 18F-ISO-1 Uptake as a Marker of Proliferation ... Twenty-eight women with 29 tumors underwent 18F-ISO-1 PET/CT scans before initiation of any cancer-directed therapy. The age range was 32–79 y (median, 55 y).