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[18F]-ML-10 PET Imaging for Cancer Detection

Phase 2

Waitlist Available

Led By Heron Dwight, MD

Research Sponsored by Aposense Ltd.

Eligibility Criteria Checklist

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

Must have

A measurable primary tumor with at least one diameter > 2 cm or primary tumor extending to one or more lymph nodes which cannot be distinctively delineated as confirmed by a diagnostic quality chest CT performed within 4 weeks prior to initiation of the concurrent CRT

Previously untreated, histologically or cytologically confirmed stage III-IV disease without evidence of distant metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will use [18F]-ML-10 PET imaging in conjunction with MRI or CT to attempt to make this distinction earlier in the course of therapy.

Who is the study for?

Adults with newly diagnosed non-small cell lung cancer or squamous cell carcinoma of the head and neck, without distant metastases. They must be able to lie still for PET/CT imaging sessions, have a performance status allowing daily activities with effort or less, and use contraception if necessary. Excluded are those with certain types of lung cancer histology, planned non-platinum chemotherapy, brain metastases signs without proper scans, unstable medical conditions, recent investigational drug use, pregnancy/lactation.Check my eligibility

What is being tested?

[18F]-ML-10 combined with PET imaging is being tested as an early detection tool for tumor response to chemoradiation therapy in patients with specific lung and head/neck cancers. The study aims to identify responders versus non-responders during treatment rather than after completion using traditional anatomical imaging like CT or MRI.See study design

What are the potential side effects?

[18F]-ML-10 is an investigational radiotracer used in PET scans; potential side effects may include reactions at the injection site or allergic responses. However, since it's primarily used for imaging purposes within a controlled clinical setting under supervision, significant side effects are not commonly expected.

Eligibility Criteria

Inclusion Criteria

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

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My tumor is larger than 2 cm or has spread to my lymph nodes, confirmed by a recent CT scan.

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My cancer is at stage III-IV and has not spread to distant parts of my body.

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I can take care of myself and am up and about more than half of my waking hours.

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I've had tests within the last month to determine my cancer stage, including brain scans if needed.

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I am not pregnant and will use birth control as advised by my doctor.

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My cancer is at stage IIB, IIIA, or IIIB and has not spread to distant parts of my body.

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I am scheduled for combined chemotherapy and radiation treatment, with the radiation dose not exceeding 70 Gy.

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My tumor and a lymph node are each at least 2 cm big, confirmed by a recent CT scan.

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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy.

Secondary outcome measures

To assess the correlation between the changes in the uptake of [18F]-ML-10 in the target lesion and the changes in the anatomical dimensions of the target lesion.

To assess the safety of [18F]-ML-10 administered to cancer patients receiving concurrent CRT.

To identify at least one parameter, derived from the changes in [18F]-ML-10 uptake that can discriminate tumors responsive to treatment from tumors that are non-responsive.

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18F]-ML-10Experimental Treatment1 Intervention

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aposense Ltd.Lead Sponsor

3 Previous Clinical Trials

41 Total Patients Enrolled

Heron Dwight, MDPrincipal InvestigatorUniversity of Pittsburgh Medical Center

David Sher, MD, MPHPrincipal InvestigatorBWH, Harvard

1 Previous Clinical Trials

72 Total Patients Enrolled

Media Library

[18F]-ML-10 in conjunction with PET imaging Clinical Trial Eligibility Overview. Trial Name: NCT01260480 — Phase 2

Head and Neck Cancers Research Study Groups: [18F]-ML-10

Head and Neck Cancers Clinical Trial 2023: [18F]-ML-10 in conjunction with PET imaging Highlights & Side Effects. Trial Name: NCT01260480 — Phase 2

[18F]-ML-10 in conjunction with PET imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT01260480 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients still needed for this particular research project?

"The listing for this trial on clinicaltrials.gov suggests that they are not currently enrolling patients. This particular study was posted on December 1st, 2010 and last updated two weeks later. Even though this specific trial is not recruiting right now, there are nearly 1800 other trials with open enrollment periods."

Answered by AI

At how many different locations can patients participate in this clinical trial?

"Mount Sinai, BWH, and Holy Name Medical Center are just a few of the six sites that are running this trial."

Answered by AI

Is [18F]-ML-10 dangerous when used with PET imaging for patients?

"[18F]-ML-10's safety is estimated to be a 2. This is due to the lack of efficacy data, as this is only a Phase 2 trial. There has been some clinical evidence supporting its safety though."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation

2010. "An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01260480.

All > Non Small Cell Lung Cancer > New Jersey