B-Cell NeoplasmPhase 2NCT02599194
18F-FSPG PET/CT for Cancer Patients on Therapy
A Phase 2 study testing 18F-FSPG and 18F-FDG in people with B-Cell Neoplasm and Estrogen Receptor Negative, run by Andrei Iagaru at 1 site in United States.
Trial summary
The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative
- What is being tested?
- 18F-FSPG and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 14 Dec 2016
- Phase
- Phase 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
- Written informed consent
- Able to complete a PET/CT scan without the use of sedation
- Females:
- Of childbearing potential must:
- Not be nursing
- Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT
Show all 14Show fewer
- Not of childbearing potential must be:
- Physiologically postmenopausal (cessation of menses for more than 1 year)
- Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)
- Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
- Scheduled to begin therapy
- The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)
- Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)
- No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week
Who cannot join
- Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
- Known sensitivity to 18F FSPG or components of the preparation
- Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94304
About this study
Official title: An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.
Read the detailed description
OUTLINE:
Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.
PRIMARY OBJECTIVE:
Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.
SECONDARY OBJECTIVES:
- Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.
- Safety and tolerability of 18F-FSPG and 18F-FDG.
- Conditions
- B-Cell Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Metastatic Renal Cell Cancer, Progesterone Receptor Negative, Stage III Mesothelioma
- Being tested
- 18F-FSPG, 18F-FDG
- Medical subject headings
- Lymphoma, B-Cell, Carcinoma, Renal Cell, Mesothelioma, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FSPGDrug
Also called 18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid, 18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate, BAY94-9392
Administered intravenously (IV)
18F-FDGDrug
Also called [18F]-Fluorodeoxyglucose ([18F]-FDG)
Administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| 18F-FSPG and 18F-FDG Intragroup Comparision | Experimental | Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. Receives: Drug: 18F-FSPG; Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
Measured: Baseline and up to 2 years
Secondary outcomes (2)
Number of Treatment-Related Adverse Events
Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.
Measured: Baseline to up to 2 years
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
Measured: Baseline and up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startJul 2015
- Primary completion14 Dec 2016
- Study completion14 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-Cell NeoplasmStudies 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
- Model description
- Intra-patient comparison of 2 different radiolabels
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrei Iagaru
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei M Iagaru, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599194
- Sponsor's protocol ID
- IRB-31855
- Other IDs
- NCI-2015-01125, VARIMG0006, P30CA124435
- Status last verified
- Dec 2018
- First submitted
- 1 Nov 2015
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park P, Hatami N, Rutledge O, Koglin N, Loo B, Fan A, Mittra E. J Nucl Med. 58(suppl 1, no 118), 1 May 2017.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
- ClinicalTrials.gov ID
- NCT02599194
- Acronym / sponsor ID
- IRB-31855
- Conditions
- B-Cell Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Metastatic Renal Cell Cancer, Progesterone Receptor Negative, Stage III Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Andrei IagaruUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2015 (actual)
- Primary completion
- 14 Dec 2016 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.
Detailed description
OUTLINE:
Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.
PRIMARY OBJECTIVE:
Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.
SECONDARY OBJECTIVES:
- Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.
- Safety and tolerability of 18F-FSPG and 18F-FDG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intra-patient comparison of 2 different radiolabels
| Arm | Type | Receives |
|---|---|---|
| 18F-FSPG and 18F-FDG Intragroup Comparision | Experimental | Drug: 18F-FSPG, Drug: 18F-FDGParticipants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Written informed consent
- Able to complete a PET/CT scan without the use of sedation
- Females:
- Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
- Scheduled to begin therapy
Key exclusion criteria (3 listed)
- Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
- Known sensitivity to 18F FSPG or components of the preparation
- Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
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-FSPGAlso: 18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid, 18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate, BAY94-9392Administered intravenously (IV) | Drug | 18F-FSPG and 18F-FDG Intragroup Comparision |
| 18F-FDGAlso: [18F]-Fluorodeoxyglucose ([18F]-FDG)Administered intravenously (IV) | Drug | 18F-FSPG and 18F-FDG Intragroup Comparision |
Primary outcome
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
Time frame: Baseline and up to 2 years
Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
2 secondary outcomes
Number of Treatment-Related Adverse Events
Time frame: Baseline to up to 2 years
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
Time frame: Baseline and up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationPark P, Hatami N, Rutledge O, Koglin N, Loo B, Fan A, Mittra E. J Nucl Med. 58(suppl 1, no 118), 1 May 2017.
- Individual participant dataSharing planned: No
Related trials for B-Cell Neoplasm
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Andrei M Iagaru, MD principal investigator
Stanford University
1 site 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-FSPG and 18F-FDG in people with B-Cell Neoplasm and Estrogen Receptor Negative, run by Andrei Iagaru 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 14 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 Jan 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 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?
Yes. Results are posted in the registry (first posted 3 Jan 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 Standard Uptake Value Maximum (SUVmax) Post-treatment (time frame: Baseline and up to 2 years). 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 NCT02599194, which also lists 1 linked publication.
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 Jan 2019.