What is the mechanism of action of this treatment?

Common cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while radiation therapy damages the DNA of cancer cells, leading to cell death. Targeted therapies, such as tyrosine kinase inhibitors, block specific molecules involved in cancer cell growth and survival. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. The investigational imaging agent 68Ga-FAPi-46 PET/CT targets fibroblast activation protein (FAP) in cancer-associated fibroblasts, which are cells that support tumor growth and progression. This imaging technique helps in identifying the extent and location of tumors, enabling more precise treatment planning. Understanding these mechanisms is crucial for cancer patients as it allows for personalized treatment strategies that can improve outcomes and reduce side effects.

What side effects are associated with this type of intervention?

Common cancer treatments such as chemotherapy, targeted therapy, and immunotherapy have a range of side effects. Chemotherapy often causes nausea, fatigue, hair loss, and peripheral neuropathy. Targeted therapies, like afatinib and gefitinib, can lead to skin rashes, diarrhea, and liver function abnormalities. Immunotherapies, such as durvalumab, may result in immune-related adverse events including pneumonitis, colitis, and endocrinopathies. These treatments aim to target cancer cells but can also affect normal cells, leading to these side effects.

What prior FDA approvals exist?

The FDA has approved various treatments for cancer, including targeted therapies and immunotherapies. For instance, lutetium Lu 177 vipivotide tetraxetan has been approved for PSMA-positive metastatic castration-resistant prostate cancer, which is a radioligand therapy targeting specific proteins expressed by cancer cells. Additionally, tyrosine kinase inhibitors like cabozantinib and regorafenib have been approved for certain cancers, targeting specific molecular pathways involved in tumor growth. While specific FDA approvals for imaging techniques like 68Ga-FAPi-46 PET/CT are not mentioned, these examples illustrate the FDA's focus on targeted and personalized cancer treatments.

What other types of research exist?

Promising alternatives to 68Ga-FAPi-46 PET/CT for cancer imaging include 18F-FDG PET/CT, which is widely used for detecting increased glucose metabolism in cancer cells, and PSMA PET, particularly for prostate cancer. Additionally, whole-body MRI and advanced PET tracers like 177Lu-Dotatate for neuroendocrine tumors are also notable options.

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FAPi PET/CT Imaging for Cancer (FAPI PET RDRC Trial)

Phase 1

Recruiting

Led By Jeremie Calais

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis

Patient is able to remain still for duration of imaging procedure (up to one hour)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to year 2

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new scan to help see where cancer is in patients. The scan highlights cancer cells, which could help doctors find and understand cancer better.

Who is the study for?

This trial is for adults with various cancers, including brain, bladder, testicular, skin, thyroid, liver cancer and more. Participants must be able to stay still for imaging procedures up to an hour and are scheduled for surgery or biopsy of the tumor. Pregnant or nursing individuals or those starting new cancer therapies before the study's PET/CT scans cannot join.

What is being tested?

The study tests a new imaging technique using 68Ga-FAPi-46 PET/CT to see how well it shows where FAPI tracer accumulates in both normal and cancer tissues. This could help understand different cancers better by visualizing a protein associated with tumor-surrounding cells.

What are the potential side effects?

As this is an imaging study involving PET/CT scans with tracers like Gallium Ga 68 FAPi-46 and not drug treatments, side effects may include discomfort from staying still during the scan and exposure to radiation typical of such diagnostic procedures.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for surgery to remove or biopsy my cancer.

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I can stay still for up to an hour.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to year 2

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to year 2

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to year 2 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Biodistribution of gallium 68Ga-FAPi-46 in normal and cancer tissues

Secondary study objectives

68Ga-FAPI-46 biodistribution correlation with 18F-FDG biodistribution

68Ga-FAPi-46 accumulation observed by positron emission tomography (PET)/computed tomography (CT)

Other study objectives

Positron-Emission Tomography

Awards & Highlights

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: Basic science (68GA-FAPI-46 PET/CT)Experimental Treatment4 Interventions

Patients receive 68Ga-FAPi-46 intravenously (IV), and then undergo PET/computed tomography (CT) over 20-90 minutes. On another day, patients receive 18F-FDG and then undergo PET/computed tomography (CT) according to standard of care procedures (if applicable).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-FDG

2017

Completed Phase 4

~750

Positron Emission Tomography

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2740

0 / 3Eligibility 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 cancer treatments work through various mechanisms to target and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while radiation therapy damages the DNA of cancer cells, leading to cell death. Targeted therapies, such as tyrosine kinase inhibitors, block specific molecules involved in cancer cell growth and survival. Immunotherapy boosts the body's immune system to recognize and attack cancer cells. The investigational imaging agent 68Ga-FAPi-46 PET/CT targets fibroblast activation protein (FAP) in cancer-associated fibroblasts, which are cells that support tumor growth and progression. This imaging technique helps in identifying the extent and location of tumors, enabling more precise treatment planning. Understanding these mechanisms is crucial for cancer patients as it allows for personalized treatment strategies that can improve outcomes and reduce side effects.

Design and validation of fibroblast activation protein alpha targeted imaging and therapeutic agents.Precision Oncology Framework for Investigation of Exercise As Treatment for Cancer.