AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 2NCT01610544

18F FLT Imaging Studies of Treatment Response for Lung Cancer and Thymoma

A Phase 2 study testing 3'-deoxy-3'-18F fluorothymidine (FLT) and PET/CT scan in people with Carcinoma, Non-Small-Cell Lung and Thymus Neoplasms, run by National Cancer Institute (NCI).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

Background: Imaging studies like positron emission tomography (PET) and computed tomography (CT) scans are used to detect tumor responses to cancer treatment. However, it may be difficult to detect early response to lung cancer or thymoma treatment with standard PET/CT scans. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
3'-deoxy-3'-18F fluorothymidine (FLT) and PET/CT scan
How many people
0 participants
Where
No sites listed yet
Study dates
10 May 2012to 10 Dec 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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects with pathology proven lung cancer or thymic malignancy already enrolled in an NCI treatment protocol usingAZD6244 in NSCLC and IMC-A12, in thymoma.
  • Participant must be 18 years or older
  • ECOG Performance score of 0 to 2
  • Ability to provide informed consent. All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of this study before any protocol related studies are performed.
  • Participants must NOT be pregnant or intend to become pregnant within 1 week of the last injection of (18)F FLT

Who cannot join

  • Known allergy to fluorothymidine
  • Participants for whom enrollment would significantly delay (> 2 weeks) the scheduled standard of care therapy
  • Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded
  • Participants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing >136 kg (weight limit for scanner table)
  • Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures

About this study

Official title: A Pilot Study of 18F FLT PET/CT in Evaluating Early Response to Anti-Proliferative Therapies in Non Small Cell Lung Cancer and Thymic Tumors

Background:

  • Imaging studies like positron emission tomography (PET) and computed tomography (CT) scans are used to detect tumor responses to cancer treatment. However, it may be difficult to detect early response to lung cancer or thymoma treatment with standard PET/CT scans. These scans cannot easily show a difference between remaining cancer cells and inflammation. Researchers want to try a new PET/CT scan tracer that may be able to show the difference between these cells. 18F-Fluorothymidine (18F-FLT) is better at showing which cells are still actively dividing. PET/CT scans with 18F-FLT may help show if tumor cells are responding to early stages of treatment.
Read more

Objectives:

  • To see if 18F-FLT is a safe and effective imaging study tracer to show early cancer response to treatment.

Eligibility:

  • Individuals at least 18 years of age who are being treated for lung cancer or thymoma.

Design:

  • Participants will be screened with a physical exam and medical history. Blood, urine, and tumor tissue samples will be collected.
  • Participants will have two PET/CT scans on separate days before starting chemotherapy. One scan will be with a standard radiotracer. The other will be with the 18F-FLT tracer.
  • About 2 weeks after starting chemotherapy, participants will repeat the two PET/CT scans on separate days. Additional blood samples will be collected at this time.
Read the detailed description

Background:

  • (18)F FLT, a thymidine analog, has uptake in tumors that correlates with proliferative rates and may be an early predictor of tumor response.
  • Due to uptake in inflammatory tissues, routinely used (18)F FDG PET/CT is often unable to distinguish therapeutic response from reactive change early in therapy.
  • Molecularly targeted therapies relating to the MEK kinase pathway in non small cell lung cancer (NSCLC) and the IGF pathway (anti-IGF-1R monoclonal antibodies) in thymoma, affect tumor proliferation.
  • We intend to explore the potential utility of (18)F FLT PET/CT imaging as an early marker of therapeutic response in molecularly targeted therapies relating to the MEK kinase pathway in NSCLC and the IGF pathway in thymic tumors.

Objectives:

-To explore the relationship between change in (18)F FLT tumor uptake (pre-treatment and soon after initiation of treatment (2 weeks)) and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab

Eligibility:

  • Subjects with pathology proven lung cancer or thymoma enrolled in an NCI therapy protocol.
  • Participant must be 18 years or older and have ECOG Performance of less than or equal to 2.
  • Patients must have measurable disease by RECIST criteria.
  • Patients must have the ability to provide informed consent. All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

Design:

-This is a pilot study which will incorporate (18)F FLT and (18)F FDG PET/CT imaging sessions prior to therapy with AZD6244, Selumetinib, in NSCLC and IMC-A12, Cixutumumab, in thymoma, and 2 weeks (+/- 4 days) following therapy initiation. The imaging parameters will be evaluated with respect to clinical response (as determined under the referring protocol). We expect to enroll 24 evaluable patients in this single center study.

Being tested
3'-deoxy-3'-18F fluorothymidine (FLT), PET/CT scan
Keywords
Thymoma, Insulin Growth Factor, Cell Proliferation, Non Small Cell Lung Cancer, PET/CT Imaging Sessions
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Thymus Neoplasms, Thymoma, Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3'-deoxy-3'-18F fluorothymidine (FLT)Drug

  • PET/CT scanOther

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To explore the relationship between change in 18F FLT tumor uptake and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab

Secondary outcomes (2)

  1. To explore the relationship between the absolute pre-treatment 18F FLT uptake and the clinical response to therapy

  2. To determine if the change in 18F FLT uptake is different from the change in 18F FDG PET/CT at the same time points

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2012 (estimated)
  2. Study start10 May 2012
  3. Primary completion10 Dec 2012
  4. Study completion10 Dec 2012

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01610544
Sponsor's protocol ID
120130
Other IDs
12-C-0130
Status last verified
10 Dec 2012
First submitted
31 May 2012
Last updated
5 Jul 2018
Results posted
No

Publications

  • McKian KP, Haluska P. Cixutumumab. Expert Opin Investig Drugs. 2009 Jul;18(7):1025-33. doi: 10.1517/13543780903055049.

    PubMed 19548856

  • Shields AF, Mankoff DA, Link JM, Graham MM, Eary JF, Kozawa SM, Zheng M, Lewellen B, Lewellen TK, Grierson JR, Krohn KA. Carbon-11-thymidine and FDG to measure therapy response. J Nucl Med. 1998 Oct;39(10):1757-62.

    PubMed 9776283

  • Vesselle H, Grierson J, Muzi M, Pugsley JM, Schmidt RA, Rabinowitz P, Peterson LM, Vallieres E, Wood DE. In vivo validation of 3'deoxy-3'-[(18)F]fluorothymidine ([(18)F]FLT) as a proliferation imaging tracer in humans: correlation of [(18)F]FLT uptake by positron emission tomography with Ki-67 immunohistochemistry and flow cytometry in human lung tumors. Clin Cancer Res. 2002 Nov;8(11):3315-23.

    PubMed 12429617

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3'-deoxy-3'-18F fluorothymidine (FLT) and PET/CT scan in people with Carcinoma, Non-Small-Cell Lung and Thymus Neoplasms, run by National Cancer Institute (NCI).

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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To explore the relationship between change in 18F FLT tumor uptake and progression free survival in NSCLC patients treated with AZD6244 and in thymoma patients with IMC-A12, Cixutumumab. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01610544, which also lists 3 linked publications.

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 5 Jul 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in