What side effects are associated with this type of intervention?

Common treatments for breast carcinoma, particularly those involving radiotracers emitting radiation for imaging such as Fluciclovine PET/CT and PSMA PET/CT, may include side effects like radiation exposure risks, which can potentially lead to radiation-induced damage to surrounding tissues. Broader treatment side effects for breast carcinoma include fatigue, weakness, insomnia, chemotherapy-induced peripheral neuropathy (CIPN), lymphedema, and drug-induced arthralgia. These side effects vary depending on the specific treatment modalities used, such as surgery, radiotherapy, chemotherapy, and hormonal therapy.

What prior FDA approvals exist?

The FDA has approved various radiotracers for imaging in cancer treatment, though specific approvals for breast carcinoma using radiotracers like Fluciclovine and PSMA are less common. Radiotracers such as 18F-FDG (fluorodeoxyglucose) are widely used in PET/CT scans for various cancers, including breast cancer, to detect and monitor metastatic disease. These imaging agents help in staging and assessing the response to therapy. The ongoing trial with Fluciclovine and PSMA PET/CT aims to improve the classification and staging of invasive lobular breast cancer, potentially leading to more precise and effective treatment strategies.

What other types of research exist?

Promising novel alternatives to Fluciclovine PET/CT and PSMA PET/CT for breast carcinoma patients include Gallium-68 DOTATATE PET/CT, which has shown efficacy in neuroendocrine tumors and could be explored for breast cancer imaging. Additionally, Lutetium-177 dotatate, used in peptide receptor radionuclide therapy, represents a novel therapeutic approach that might be adapted for breast carcinoma treatment.

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PET/CT with Tracers for Breast Cancer

Phase 1

Waitlist Available

Led By David M Schuster, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment naive biopsy proven ILC patients with ILC

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial uses special substances that emit tiny amounts of radiation to create detailed images of the inside of the body. It targets patients with a specific type of breast cancer that may have spread. The substances help highlight cancer spots during scans, aiding doctors in better detecting and understanding the spread of cancer.

Who is the study for?

This trial is for patients with invasive lobular breast cancer that may have spread, who haven't started treatment yet. They should be open to biopsies if needed. Pregnant women or those able to conceive without being postmenopausal for at least a year (if over 55) can't join.

What is being tested?

The study tests how well two PET/CT imaging scans using fluciclovine and PSMA radiotracers work in classifying and staging invasive lobular breast cancer that might have metastasized.

What are the potential side effects?

Since this trial involves diagnostic imaging rather than drug treatments, side effects are minimal but may include discomfort from the procedure or reactions to the tracers used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have invasive lobular carcinoma (ILC) and haven't received any treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Verified detection rate for invasive lobular breast cancer

Verified detection rate for metastasis

Other study objectives

Imaging results

Presence or absence of metastasis

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (Ga PSMA, fluciclovine F18, PET/CT)Experimental Treatment4 Interventions

Patients receive gallium Ga 68-labeled PSMA-11 IV and undergo a PET/CT scan over 30 minutes. On a separate day, patients receive fluciclovine F18 IV and undergo a PET/CT scan over 30 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2790

Urea

FDA approved

Fluciclovine (18F)

FDA approved

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast carcinoma include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Radiotracers like Fluciclovine and PSMA used in PET/CT imaging emit radiation that helps visualize cancer spread, aiding in accurate staging and treatment planning. This matters for breast carcinoma patients as precise imaging can lead to more tailored and effective treatment strategies, potentially improving outcomes and reducing unnecessary treatments.

Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial.Ductal carcinoma in situ: recent advances and future prospects.Preclinical and clinical evaluation of intraductally administered agents in early breast cancer.