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Advanced CancersPhase 1NCT02193672

A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide to Correlate With Response to Anti-Cancer Therapy

A Phase 1 study testing [18F] Fluciclatide, PET/CT Scan and Phone Calls in people with Advanced Cancers, run by M.D. Anderson Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of this clinical research study is to find out if using the tracer (liquid used in imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography (PET/CT) scans will help researchers learn more quickly if the disease is responding to treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancers
What is being tested?
[18F] Fluciclatide, PET/CT Scan and Phone Calls
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2014to Aug 2020
Phase
Phase 1
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

  • Patient is >/= 18 years and male or female of any race/ethnicity.
  • Patient or patient's legally authorized representative provides written informed consent and is willing to comply with protocol requirements.
  • Patient must be scheduled to receive an anti-VEGF inhibitor (bevacizumab, sorafenib, sunitinib, other), mTOR inhibitor (temsirolimus, everolimus, other), or other molecules with antiangiogenic properties including taxol as anti-cancer therapy.
  • Patient must have normal hepatic and renal function defined as: 1) AST (SGOT)/ALT (SGPT) </=3 x institutional upper limit of normal and 2) serum creatinine </= 2x institutional upper limit of normal.
  • Platelet count of > 75 x 10^3/μL
  • Patients may participate in clinical trials in the Phase I program.
  • Patients with any solid tumor type.

Who cannot join

  • Patient is not capable of complying with study procedures.
  • Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following: 1) Confirming in medical history that the patient is postmenopausal defined as 12 consecutive months of amenorrhea, or surgically sterile, 2) Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: Intrauterine device (IUD), oral contraceptives, Depo-Provera, or Norplant, 3) Confirming a negative urine dipstick test taken the morning of receiving the investigational agent [18F]fluciclatide.

About this study

The goal of this clinical research study is to find out if using the tracer (liquid used in imaging scans) [18F]fluciclatide in positron emission tomography / computed tomography (PET/CT) scans will help researchers learn more quickly if the disease is responding to treatment.

Read the detailed description

PET/CT Scans:

If you are found eligible to take part in this study, you will have a PET/CT scan at your treatment baseline visit, about 1 week before your first cycle of chemotherapy. You will then have a second PET/CT scan at the end of your first cycle of chemotherapy (about 3-4 weeks after starting chemotherapy).

For up to 6 hours before the PET/CT scan, you must not eat or drink anything except water. A small needle and tube will be placed in your arm, and you will receive an injection of a very small amount of a mildly radioactive material into your bloodstream (the investigational tracer, [18F]fluciclatide). The radioactive nature of this injected material allows the scanner to "see" it in certain places in your body. After the injection, you will need to rest quietly until it is time for the scan. The amount of rest time may vary, but be prepared to wait for between 45 and 90 minutes. During the scan, you will lie flat on your back on a table. The scan itself may last up to 1 hour.

Each PET/CT imaging session will last about 4 hours total from the time you arrive at the clinic until you are discharged and allowed to go home. You may be discharged 30 minutes after the scan is complete, if the doctor thinks you are clinically stable and it is safe for you to leave.

Study Visits:

If the following tests are already being performed as part of the clinical research study you are participating in or as part of standard care, they will not need to be repeated for this study.

Baseline Visit (before the first PET/CT is performed):

  • You will have a physical exam.
  • Blood (about 3 tablespoons) will be drawn for routine tests.
  • If you can become pregnant, urine will be collected for a pregnancy test. To take part in this study, you must not be pregnant.

End of Cycle 1 (before the second PET/CT is performed):

-Blood (about 3 tablespoons) will be drawn for routine tests.

About 24 hours after each PET/CT is performed, the study staff will call you by telephone to ask about your health status and any side effects you may be experiencing.

Anytime within the next month after the second PET/CT scan, blood (about 3 tablespoons) will be drawn for routine tests.

When your chemotherapy is over, you will have a third PET/CT scan as part of your standard care, and an FDG tracer will be used for that scan.

Length of Participation:

Your study participation will end about 6 weeks after your second PET/CT scan is performed.

This is an investigational study. [18F]Fluciclatide is not FDA approved or commercially available. At this time, it is only being used in research.

Up to 50 patients will take part in this research study. All will be enrolled at MD Anderson.

Being tested
[18F] Fluciclatide, PET/CT Scan, Phone Calls
Keywords
Advanced cancers, PET/CT, Positron emission tomography / computed tomography, [18F]Fluciclatide, Chemotherapy, Phone calls

What participants receive

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

  • [18F] FluciclatideDrug

    [18F] Fluciclatide given by vein before PET/CT scan.

  • PET/CT ScanProcedure or surgery

    Also called Positron emission tomography / computed tomography

    PET/CT scan performed at treatment baseline visit, and about 1 week before first cycle of chemotherapy. Then, a PET/CT scan performed at end of first cycle of chemotherapy.

  • Phone CallsBehavioural

    Phone call to participants by study staff about 24 hours after each PET/CT is performed.

Study groups in NCT02193672
Study groupRoleWhat they receive
PET/CT + [18F]FluciclatideExperimentalAt baseline: Participants have PET/CT imaging within 7 days prior to initiation of chemotherapy treatment. Participants monitored at 24 hours post scan via telephone. On treatment: Participants have PET/CT imaging at end of the first cycle and prior to the initiation of the second cycle of chemotherapy. Participants assessed at 24 hours post scan via telephone call. Baseline and on treatment PET/CT imaging performed with agent [18F] Fluciclatide.
Receives: Drug: [18F] Fluciclatide; Procedure: PET/CT Scan; Behavioral: Phone Calls

What is being measured

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

  1. Change in Tumor Uptake

    Primary efficacy endpoint is change in tumor uptake of investigational agent [18F]Fluciclatide, as measured by standardized uptake value (SUVFluciclatide) from before treatment to after one cycle of treatment but before the second cycle starts. This determined from investigational agent [18F]Fluciclatide PET scans. Changes in SUVFluciclatide compared to standard tumor's response measured after completion of 2 cycles of treatment as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) as well as tumor size change as a continuous variable measured by the standard CT or PET/CT scans. Tumor size can also be measured by the WHO two-dimensional measurement in addition to the Response Evaluation Criteria in Solid Tumors (RECIST), one-dimensional measurement. Changes in SUVFluciclatide after one cycle also compared to tumor volume and tumor size as continuous variables after two cycles.

    Measured: After 2, four week chemotherapy cycles

Timeline

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

  1. First posted18 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2020 (estimated)

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 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02193672
Sponsor's protocol ID
2013-0591
Status last verified
Jul 2014
First submitted
11 Jul 2014
Last updated
18 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F] Fluciclatide, PET/CT Scan and Phone Calls in people with Advanced Cancers, run by M.D. Anderson Cancer Center.

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 7 inclusion and 2 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 18 Jul 2014. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Change in Tumor Uptake (time frame: After 2, four week chemotherapy cycles). 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 NCT02193672.

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 18 Jul 2014.

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