PET Imaging of the Immune System Using Analog Probes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-10

Study Completion Date

2020-11-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this proposal is to assess the biodistribution of 18F-Clofarabine, a new tracer developed for use in PET/CT scans. The investigator's hypothesis is this tracer will allow for imaging immune activation in patients with melanoma before and after treatment with immunotherapy.

A maximum of 10 subjects are intended to be included in this study. Each subject will undergo a maximum of two 18F-Clofarabine PET/CT scans, with each visit taking up to 4 hours. The first visit will be prior to the first cycle of immunotherapy treatment, and the second scan will take place 2-4 weeks after the immunotherapy treatment has started.

Prior to the PET scan an IV line will be placed. Blood pressure, heart rate, blood oxygen and ECG will be obtained. Then the 18F-Clofarabine will be injected and the PET/CT scan acquisition started. After a maximum of 120 min of scanning, subjects will undergo again blood pressure, heart rate, blood oxygen and ECG.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

18F-Clofarabine PET/CT in Imaging Cancer Patients Before and After Interventions

NCT02888301

Malignant Neoplasm

TERMINATED

Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer

NCT06457789

NSCLC

RECRUITING NA

PD-L1 PET Imaging in Melanoma Patients

NCT03520634

Melanoma

COMPLETED NA

Imaging Advanced NSCLC Patients Undergoing PD-1/PD-L1 Directed Therapy Using [18F]-FARAG

NCT06107374

Advanced Non Small Cell Lung Cancer

RECRUITING PHASE2

A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation

NCT00847509

Lung Cancer Head and Neck Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a non-interventional pilot study dedicated to PET imaging for patients with metastatic or recurrent advanced cancer melanoma before and after immune therapy interventions with an anti-TIM-3 monoclonal antibody, with or without an anti-PD1 antibody.

PET/CT will be used to investigate the bio-distribution of 18F-Clofarabine in patients with advanced or metastatic melanoma before and 2 to 4 weeks after immune system activating interventions, namely an anti-TIM-3 monoclonal antibody, alone or in combination with an anti-PD1 antibody. Clofarabine is a FDA-approved drug for treatment of relapsed or refractory pediatric acute lymphoblastic leukemia (December 2004) and is gaining importance for treating adult patients with acute myeloid leukemia. Despite extensive preclinical toxicity studies and multiple human phase I studies, the exact bio-distribution of Clofarabine remains unknown. The labeling of Clofarabine with 18F allows the in vivo imaging of its bio-distribution using only minimal concentrations of the therapeutically active doses. The radioactive labeling of clofarabine does not change the parent molecule since a 19F present in the parent compound is simply replaced by an 18F.

The investigators hypothesize that imaging the bio-distribution of clofarabine non-invasively will provide insights into the bio-distribution of the drug in vivo. Imaging the bio-distribution of radiolabeled Clofarabine may help to better understand the side effects caused by therapeutic doses. Importantly, the investigators want to understand if interventions activating the immune system impact the bio-distribution of 18F-Clofarabine. This is because the enzyme dCK that is required to activate the prodrug clofarabine is highly expressed in activated immune cells (3).

Dynamic PET/CT imaging with 18F-Clofarabine will be performed in 10 patients with advanced or metastatic melanoma who have progressed following treatment with an anti-PD-1 antibody. 18F-Clofarabine PET/CT scans will be collected before and 2-4 weeks after treatment with an anti-TIM-3 monoclonal antibody, with or without an anti-PD1 antibody. Imaging can be completed without exposing human subjects to any significant risk. It should be noted, that only trace amounts (nano-molar concentrations in saline solution) of the labeled 18F-Clofarabine will be administered intravenously. Thus, mass effects of the drug and any toxic effects can be ruled out. Tracer concentrations in all organs can be quantified non-invasively in organs which may provide insights into the whole-body drug distribution. Investigators have now seen in humans and non-human primates the exact bio-distribution that one would expect with uptake in bone marrow, spleen, LN and, if patients are young, in thymus. Liver uptake is non-specific and likely due to hepatic clearance via biliary system. There is no retention in other organs which does not mean that there is no low background activity. Tracer uptake is proportional to dCK activity in tissues.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pre cohort

Each subject will undergo a maximum of two 18F-Clofarabine PET/CT scans with each visit taking up to 4 hours. The 18F-Clofarabine PET/CT scans will be performed before the treatment interventions.

[18F] CFA

Intervention Type DRUG

pilot study to evaluate the bio-distribution of \[18F\] CFA, a new tracer for imaging the purine nucleoside biosynthetic pathway, before and after immunotherapy treatment in patients with metastatic or recurrent advanced melanoma.

post cohort

Each subject will undergo a maximum of two 18F-Clofarabine PET/CT scans with each visit taking up to 4 hours. The 18F-Clofarabine PET/CT scans will be performed after the treatment interventions.

[18F] CFA

Intervention Type DRUG

pilot study to evaluate the bio-distribution of \[18F\] CFA, a new tracer for imaging the purine nucleoside biosynthetic pathway, before and after immunotherapy treatment in patients with metastatic or recurrent advanced melanoma.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[18F] CFA

pilot study to evaluate the bio-distribution of \[18F\] CFA, a new tracer for imaging the purine nucleoside biosynthetic pathway, before and after immunotherapy treatment in patients with metastatic or recurrent advanced melanoma.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

tracer for imaging the purine nucleoside biosynthetic pathway

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject must be able to tolerate PET/CT (i.e. not claustrophobic and able to remain supine)
2. Subject must be 18 years or older
3. Participation in a main study of anti-TIM-3