AzTrials
AzTrials

Adult Giant Cell GlioblastomaPhase 1/2NCT01806675

18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

A Phase 1/2 study testing 18F-fludeoxyglucose (18F-FDG) and 18F-FPPRGD2 in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by Sanjiv Sam Gambhir at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
18F-fludeoxyglucose (18F-FDG) and 18F-FPPRGD2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
4 Mar 2013to Apr 2019
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provides written informed consent
  • Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment or treatment with other drugs that may alter angiogenesis
  • Able to remain still for duration of each imaging procedure (about one hour)

Who cannot join

  • Pregnant or nursing
  • Contraindication to MRI
  • History of renal insufficiency (only for MRI contrast administration)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University, School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Phase 1-2 18F-FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis

The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.

Read the detailed description

PRIMARY OBJECTIVE

  • Evaluate 18F-FPPRGD2 and 18F-FDG as PET/CT or PET/MRI radiotracers for imaging prediction and assessment of response to anti-angiogenesis therapy in participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC).

SECONDARY OBJECTIVE

  • Progression-free survival (PFS) at up to 1 year after initial scans and treatment

OUTLINE:

Patients undergo 18F-FPPRGD2 and 18F-FDG PET/CT or PET/MRI medical imaging at baseline and at regular medical care follow-up (6 to 12 weeks).

After completion of study imaging, patients are followed up at 12 months.

Being tested
18F-fludeoxyglucose (18F-FDG), 18F-FPPRGD2
Medical subject headings
Glioblastoma, Gliosarcoma, Breast Neoplasms, Male, Brain Neoplasms, Colonic Neoplasms, Esthesioneuroblastoma, Olfactory, Hypopharyngeal Neoplasms, Laryngeal Neoplasms

What participants receive

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

  • 18F-fludeoxyglucose (18F-FDG)Drug

    Also called Fludeoxyglucose F-18, 18-FDG, FDG

    18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan

  • 18F-FPPRGD2Drug

    Also called (18F)-2-fluoropropionyl-labeled PEGylated dimeric arginine-glycine-aspartic acid peptide, [PEG3-E{c(RGDyk)}2], fluorine-18-FPPRGD2, [18F]-FPPRGD2

    18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.

Study groups in NCT01806675
Study groupRoleWhat they receive
Glioblastoma Multiforme (GBM)ExperimentalPatients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up)
Receives: Drug: 18F-fludeoxyglucose (18F-FDG); Drug: 18F-FPPRGD2
Gynecological CancersExperimentalPatients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
Receives: Drug: 18F-fludeoxyglucose (18F-FDG); Drug: 18F-FPPRGD2
Renal Cell Cancer (RCC)ExperimentalPatients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up)
Receives: Drug: 18F-fludeoxyglucose (18F-FDG); Drug: 18F-FPPRGD2

What is being measured

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

  1. Change From Baseline in Maximum Standard Uptake Values (SUVmax)

    Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.

    Measured: At baseline and 6 weeks

Secondary outcomes (4)

  1. Response Assessment by RANO Criteria

    The treatment effect for participants with glioblastoma multiforme was to be assessed on the basis of post-treatment evaluation per the Response Assessment in Neuro-Oncology (RANO) Criteria. The outcome was the number \& proportion of participants that achieved either a complete response (CR) or partial response (PR), a number without dispersion. RANO criteria are:

    CR= No T1 gadolinium (T1-G); T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) stable/decreased, no new lesions; no corticosteroids; clinical condition improved/stable.

    PR= ≥50% decrease in T1-G; T2/FLAIR decreased/stable ; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable.

    Stable disease (SD)= <50% decrease, but more than 25% increase, in T1-G; T2/FLAIR decreased/stable; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable.

    Progressive disease (PD)= ≥25%increase T1-G; T2/FLAIR increased; increased corticosteroids; clinical condition decreased

    Measured: At baseline and 6 weeks

  2. Change in Tumor Size

    The treatment effect for participants with gynecological cancers (GYN) and renal cell carcinoma (RCC) was assessed on the basis of change in tumor size as determined by pre- and post-treatment CT scans. The outcome is reported as the difference at treatment follow-up, reported as the median with standard deviation.

    Measured: 9 to 12 weeks

  3. Tumor Response Rate by EORTC Criteria

    Tumor Response Rate by EORTC Criteria Tumor response rates were assessed from position emission tomography (PET) scans using 18F-FPPRGD2 \& 18F-FDG at baseline \& after 6 weeks of treatment, per European Organization for Research \& Treatment of Cancer (EORTC) response criteria. The outcome is reported for each radiotracer by disease group as the number of participants achieving complete response (CR), partial response (PR), stable disease (SD), \& progressive disease (PD).

    • CR= complete resolution of 18F-FDG uptake tumor volume
    • PR= reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle of chemotherapy, and ≥25% after >1 cycle
    • SD= increase in tumor 18F-FDG SUVmax of <25% or a decrease of <15% \& no increase in 18F-FDG tumor uptake [>20% in the longest dimension (LD)];
    • PD= increase in 18F-FDG tumor SUVmax of >25% in tumor region on baseline; increase in extent of 18F-FDG tumor uptake (>20% in LD); appearance of new 18F-FDG uptake in metastatic lesions

    Measured: At baseline and 6 weeks

  4. Progression-free Survival (PFS)

    Progression-free survival (PFS) was defined as remaining alive at 1 year with disease progression, according to the physician's assessment of clinical status, by disease group.

    Measured: 1 year

Timeline

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

  1. First posted7 Mar 2013 (estimated)
  2. Study start4 Mar 2013
  3. Primary completion7 Dec 2016
  4. Study completionApr 2019

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 1/2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01806675
Sponsor's protocol ID
IRB-25970
Other IDs
NCI-2013-00535, IRB-25970, VARIMG0002
Status last verified
Sep 2019
First submitted
5 Mar 2013
Last updated
3 Oct 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Minamimoto R, Jamali M, Barkhodari A, Mosci C, Mittra E, Shen B, Chin F, Gambhir SS, Iagaru A. Biodistribution of the (1)(8)F-FPPRGD(2) PET radiopharmaceutical in cancer patients: an atlas of SUV measurements. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1850-8. doi: 10.1007/s00259-015-3096-4. Epub 2015 Jun 11.

    PubMed 26062933

  • Iagaru A, Mosci C, Mittra E, Zaharchuk G, Fischbein N, Harsh G, Li G, Nagpal S, Recht L, Gambhir SS. Glioblastoma Multiforme Recurrence: An Exploratory Study of (18)F FPPRGD2 PET/CT. Radiology. 2015 Nov;277(2):497-506. doi: 10.1148/radiol.2015141550. Epub 2015 May 12.

    PubMed 25965900

  • Minamimoto R, Karam A, Jamali M, Barkhodari A, Gambhir SS, Dorigo O, Iagaru A. Pilot prospective evaluation of (18)F-FPPRGD2 PET/CT in patients with cervical and ovarian cancer. Eur J Nucl Med Mol Imaging. 2016 Jun;43(6):1047-55. doi: 10.1007/s00259-015-3263-7. Epub 2015 Nov 27.

    PubMed 26611425

  • Toriihara A, Duan H, Thompson HM, Park S, Hatami N, Baratto L, Fan AC, Iagaru A. 18F-FPPRGD2 PET/CT in patients with metastatic renal cell cancer. Eur J Nucl Med Mol Imaging. 2019 Jul;46(7):1518-1523. doi: 10.1007/s00259-019-04295-7. Epub 2019 Mar 8.

    PubMed 30850872

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 18F-fludeoxyglucose (18F-FDG) and 18F-FPPRGD2 in people with Adult Giant Cell Glioblastoma and Adult Glioblastoma, run by Sanjiv Sam Gambhir at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

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?

Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Maximum Standard Uptake Values (SUVmax) (time frame: At baseline and 6 weeks). 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 NCT01806675, which also lists 4 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 3 Oct 2019.

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