Carcinoma, Non-Small-Cell LungPhase 2NCT01260480
An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation
A Phase 2 study testing [18F]-ML-10 in conjunction with PET imaging in people with Carcinoma, Non-Small-Cell Lung and Head and Neck Neoplasms, run by Aposense Ltd. at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET imaging is effective as an imaging tool for the early detection of response of oncological tumors in the lungs,head and neck to chemoradiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms
- What is being tested?
- [18F]-ML-10 in conjunction with PET imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with either:
- Newly diagnosed non small cell lung cancer (NSCLC) (Group A) who meet the following criteria:
- Previously untreated, histologically or cytologically confirmed stage IIB, IIIA or IIIB disease, without evidence of distant metastases
- 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.
- Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
- Undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
Show all 25Show fewer
- GBCA-enhanced Brain MRI or contrast enhanced CT if there are signs or symptoms suggesting brain metastases within the past 2 months.
- If necessary to confirm stage of disease, an upper abdomen CT scan will be performed.
- whole-body FDG PET/CT; OR
- Newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) (Group B) who meet the following criteria:
- Previously untreated, histologically or cytologically confirmed (from the primary tumor and/or lymph nodes) stage III-IV disease without evidence of distant metastases.
- A measurable (i) primary tumor with at least one diameter ≥2 cm and (ii) lymph node with at least one diameter ≥ 2 cm as confirmed by a diagnostic quality neck CT performed within 4 weeks prior to initiation of the concurrent CRT.
- Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
- Have undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
- Whole-body FDG PET/CT.
- Patients ≥ 18 years of age.
- Able to comply with lying still during the PET/CT imaging session which may last for up to 3 hrs with intermediate breaks.
- ECOG performance status of 0, 1 or 2.
- Adequate renal function and adequate hepatic function, as assessed by standard laboratory criteria and defined as:
- Serum creatinine ≤ 1.2 times the Upper Limit of Normal (ULN).
- Total bilirubin ≤ 1.5 times the ULN.
- Asparagine aminotransferase (AST) and/or alanineaminotransferase (ALT) ≤ 2.5 times the ULN (grade 1 according to the NCI-CTCAE v.3).
- Women of child-bearing potential must have a negative blood pregnancy test at screening and use an adequate and medically acceptable contraceptive method.
- Willing and able to comply with the protocol requirements.
- Able to provide written informed consent.
Who cannot join
- Exclusion criteria specific to patients with NSCLC (Group A):
- Predominant small cell carcinoma histology.
- Pure bronchioalveolar cell carcinoma histology.
- Treatment planned with chemotherapy other than a platinum-based doublet regimen.
- Malignant pleural or pericardial effusions.
- Any contraindication to perform CT with IV contrast agent.
Show all 16Show fewer
- Exclusion criteria specific to patients with SCCHN (Group B):
- Histology other than squamous cell carcinoma.
- Treatment planned with chemotherapy other than a platinum-based regimen.
- Treatment planned with cetuximab.
- Treatment with induction chemotherapy.
- Any contraindication to CT with IV contrast agent.
- Evidence of distant metastases.
- Patients who, based on the investigator's judgment, have other unstable medical conditions that may preclude safe and complete study participation.
- Treatment with any investigational drug, device or biologic agent within 30 days prior to administration of [18F]-ML-10.
- Pregnancy or lactation.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
BWH
Boston, Massachusetts
David Sher, MD, DSHER@PARTNERS.ORG
- Recruiting
Mount Sinai
New York, New York, 10029
Lale Kostakoglu, MD, MPH, lale.kostakoglu@msnyuhealth.org
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15232
Heron Dwight, MD, 412-623-1275
- Recruiting
Holy Name Medical Center
Teaneck, New Jersey, 07666
Benjamin Rosenbluth, MD, rosenbluth@mail.holyname.org
About this study
Official title: A Prospective, Multicenter Study, to Evaluate the Efficacy and Safety of [18F]-ML-10, a Positron Emission Tomography (PET) Imaging Radiotracer, in Early Detection of Response of Non-Hematological Tumors to Concurrent Chemoradiotherapy
The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET imaging is effective as an imaging tool for the early detection of response of oncological tumors in the lungs,head and neck to chemoradiation therapy.
The study will evaluate the potential of [18F]-ML-10 used in conjunction with PET imaging to distinguish early during the course of chemoradiation therapy between a tumor that responds to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction is available to the physician several weeks or months after completion of therapy, using anatomical imaging (for example Computed Tomography [CT] or Magnetic Resonance Imaging [MRI]).
- Being tested
- [18F]-ML-10 in conjunction with PET imaging
- Keywords
- Carcinoma, non-small-cell lung, Head and neck neoplasms, Diagnostic imaging
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-ML-10 in conjunction with PET imagingOther
Subjects will receive two to three intravenous (IV) doses of [18F]-ML-10. The dose for each [18F]-ML-10 dose will be 5.50 MBq/Kg or 0.15 mCi/Kg but will not exceed 500.00 MBq (13.50 mCi) per administration.
| Study group | Role | What they receive |
|---|---|---|
| [18F]-ML-10 | Experimental | Not described Receives: Other: [18F]-ML-10 in conjunction with PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy.
Measured: Between baseline and day 11 ± 1, and between baseline and day 18 ± 1
Secondary outcomes (4)
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 correlation between the changes in the uptake of [18F]-ML-10 in the target lesion following an accumulative radiation dose of 14.4-20.0 Gy, and the changes in the anatomical dimensions of the target lesion, as assessed by the follow-up anatomical imaging by CT, performed after completion of the concurrent chemoradiotherapy (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.
For this parameter, various cut-off values of change will be evaluated, with corresponding estimates of sensitivity and specificity.
To perform additional analyses for all other lesions and lymph nodes with at least one diameter ≥ 2 cm treated by concurrent CRT.
To assess the safety of [18F]-ML-10 administered to cancer patients receiving concurrent CRT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aposense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Heron Dwight, MD, Principal investigator, University of Pittsburgh Medical CenterDavid Sher, MD, MPH, Principal investigator, BWH, HarvardAaron Allen, MD, Study director, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260480
- Sponsor's protocol ID
- NST-CA007
- Status last verified
- Dec 2010
- First submitted
- 14 Dec 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study, to Evaluate the Efficacy and Safety of [18F]-ML-10, a Positron Emission Tomography (PET) Imaging Radiotracer, in Early Detection of Response of Non-Hematological Tumors to Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT01260480
- Acronym / sponsor ID
- NST-CA007
- Keywords
- Carcinoma, non-small-cell lung, Head and neck neoplasms, Diagnostic imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aposense Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (estimated)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether [18F]-ML-10 used in conjunction with PET imaging is effective as an imaging tool for the early detection of response of oncological tumors in the lungs,head and neck to chemoradiation therapy.
The study will evaluate the potential of [18F]-ML-10 used in conjunction with PET imaging to distinguish early during the course of chemoradiation therapy between a tumor that responds to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction is available to the physician several weeks or months after completion of therapy, using anatomical imaging (for example Computed Tomography [CT] or Magnetic Resonance Imaging [MRI]).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]-ML-10 | Experimental | Other: [18F]-ML-10 in conjunction with PET imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Newly diagnosed non small cell lung cancer (NSCLC) (Group A) who meet the following criteria:
- Previously untreated, histologically or cytologically confirmed stage IIB, IIIA or IIIB disease, without evidence of distant metastases
- 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.
- Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
- Undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
Key exclusion criteria (16 listed)
- Predominant small cell carcinoma histology.
- Pure bronchioalveolar cell carcinoma histology.
- Treatment planned with chemotherapy other than a platinum-based doublet regimen.
- Malignant pleural or pericardial effusions.
- Any contraindication to perform CT with IV contrast agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-ML-10 in conjunction with PET imagingSubjects will receive two to three intravenous (IV) doses of [18F]-ML-10. The dose for each [18F]-ML-10 dose will be 5.50 MBq/Kg or 0.15 mCi/Kg but will not exceed 500.00 MBq (13.50 mCi) per administration. | Other | [18F]-ML-10 |
Primary outcome
To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy.
Time frame: Between baseline and day 11 ± 1, and between baseline and day 18 ± 1
4 secondary outcomes
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 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.
To perform additional analyses for all other lesions and lymph nodes with at least one diameter ≥ 2 cm treated by concurrent CRT.
To assess the safety of [18F]-ML-10 administered to cancer patients receiving concurrent CRT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heron Dwight, MD principal investigator
University of Pittsburgh Medical Center
David Sher, MD, MPH principal investigator
BWH, Harvard
Aaron Allen, MD study director
Rabin Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]-ML-10 in conjunction with PET imaging in people with Carcinoma, Non-Small-Cell Lung and Head and Neck Neoplasms, run by Aposense Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy. (time frame: Between baseline and day 11 ± 1, and between baseline and day 18 ± 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2010.