Stage IIIA Fallopian Tube CancerEarly Phase 1NCT02872519
PET Imaging of Ovarian Carcinoma With 18F-FSPG
A Early Phase 1 study testing (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG), Positron Emission Tomography and Laboratory Biomarker Analysis in people with Stage IIIA Fallopian Tube Cancer and Stage IIIA Ovarian Cancer, run by Vanderbilt-Ingram Cancer Center.
Trial summary
This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients with ovarian cancer before undergoing surgery or transplant. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer
- What is being tested?
- (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG), Positron Emission Tomography and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to Aug 2020
- Phase
- Early 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal.
- Pelvic mass and/or omental caking with Ca-125:CEA ratio 25:1.
- Adequate performance status, ECOG 0, 1, 2.
- Adequate organ function:
- PCV > 30 (with or without transfusion)
- WBC: 3000 - 10,000 The lower level of normal for total WBCs is 4,000, but the NCI considers levels of 3,000- 4,000 as mild suppression for drug trials, specifically not requiring treatment.
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- Platelet count > 150, 000 and < 1,000,000
- Cr < 1.5
- LFTS < 1.5 x ULN
- Have undergone or have agreed to undergo standard of care CT of the chest, abdomen, and pelvis. 18F-FSPG PET imaging will be performed as investigational studies.
- No prior treatment for ovarian cancer
- have undergone or agree to undergo standard of care imaging for ovarian cancer with CT chest, abdomen, and pelvis.
Who cannot join
- Have non-invasive or non-epithelial ovarian cancer on pathological confirmation.
- Pregnant and breastfeeding
- Poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL).
- Other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery.
- CT of chest, abdomen, pelvis demonstrates:
- Any disease in the thoracic cavity > 1 cm.
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- Any suprarenal lymphadenopathy > 1 cm.
- Liver metastases > 1 cm.
- Disease in the porta hepatis or gallbladder fossa > 1 cm.
- Pleural effusion > 50% volume of the chest cavity on chest x-ray.
- Omental extension to the stomach, spleen, or lesser sac.
- Extension to the pelvic sidewall (this criteria may also be assessed on physical examination.
- involvement of the root of the mesentery.
- Decline procedures that might be necessary for optimal primary cytoreduction (i.e. colostomy or splenectomy).
About this study
This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has spread.
- Conditions
- Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer
- Being tested
- (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG), Positron Emission Tomography, Laboratory Biomarker Analysis
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)Drug
Given by IV
Positron Emission TomographyProcedure or surgery
Undergo scan
Laboratory Biomarker AnalysisOther
Laboratory Biomarker Analysis
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients receive (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET scans. Patients undergo PET imaging scans during 0-45 minutes, 60-75 minutes, and 105-120 minutes after injection and within 4 weeks prior to surgery (Cohort A) or within 4 weeks of SOC imaging at diagnosis and prior to subsequent treatment (Cohort B). Receives: Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG); Procedure: Positron Emission Tomography; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values
Measured: Up to 2 years
Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET
Measured: Up to 2 years
Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment
Measured: Up to 2 years
Secondary outcomes (4)
Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3.
All imaging data (SUV) will be correlated to definitive, ex vivo diagnostic pathology and immunoreactivity (xC-, CD44), which will be carried out for every patient with resected tissue. and, when IHC scoring will be in terms of strength of immunostaining (scored on an ordinal scale of 0 3). This treatment of lesion-based sensitivity and specificity has not been previously described in the ovarian cancer literature.
Measured: Up to 2 years
Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation
Measured: Up to 2 years
Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria
Measured: Up to 2 years
Conditional predictive models of imaging performance and agreement
We will test that lesion 18F-FSPG PET SUV's are significantly greater than background (normal liver tissue) by tissue assessment of number of lesions noted in each arm and after treatment.
Measured: 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 posted19 Aug 2016 (estimated)
- Study startJun 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIA Fallopian Tube CancerStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Marta Crispens, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Marta Crispens, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872519
- Sponsor's protocol ID
- VICC GYN 15142
- Status last verified
- Jun 2018
- First submitted
- 26 Jul 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Ovarian Carcinoma With 18F-FSPG
- ClinicalTrials.gov ID
- NCT02872519
- Acronym / sponsor ID
- VICC GYN 15142
- Conditions
- Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 19 Aug 2016 (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.
This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-FSPG [(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid], a glutamic acid derivative, to image patients with ovarian cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose ovarian cancer and find out how far the disease has spread.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG), Procedure: Positron Emission Tomography, Other: Laboratory Biomarker AnalysisPatients receive (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET scans. Patients undergo PET imaging scans during 0-45 minutes, 60-75 minutes, and 105-120 minutes after injection and within 4 weeks prior to surgery (Cohort A) or within 4 weeks of SOC imaging at diagnosis and prior to subsequent treatment (Cohort B). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal.
- Adequate organ function:
- Have undergone or have agreed to undergo standard of care CT of the chest, abdomen, and pelvis. 18F-FSPG PET imaging will be performed as investigational studies.
- No prior treatment for ovarian cancer
- have undergone or agree to undergo standard of care imaging for ovarian cancer with CT chest, abdomen, and pelvis.
Key exclusion criteria (14 listed)
- Have non-invasive or non-epithelial ovarian cancer on pathological confirmation.
- Pregnant and breastfeeding
- Poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL).
- Other poorly controlled medical conditions that in the opinion of the surgeon, make them not a candidate for primary cytoreductive surgery.
- CT of chest, abdomen, pelvis demonstrates:
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 |
|---|---|---|
| (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)Given by IV | Drug | Experimental |
| Positron Emission TomographyUndergo scan | Procedure or surgery | Experimental |
| Laboratory Biomarker AnalysisLaboratory Biomarker Analysis | Other | Experimental |
Primary outcome
Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values
Time frame: Up to 2 years
Number of lesions detected by(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET
Time frame: Up to 2 years
Number of lesions detected by (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET imaging before and after neoadjuvant chemotherapy treatment
Time frame: Up to 2 years
4 secondary outcomes
Immunohistochemistry evaluation of xC- and CD 44 of resected malignant ovarian cancer with a measurement of strength of staining from 0-3.
Time frame: Up to 2 years
Proportion of patients whose surgical resection by novel imaging classification changed following validation by histological confirmation
Time frame: Up to 2 years
Proportion of patients whose response to chemotherapy changed by Response Evaluation Criteria in Solid Tumors criteria
Time frame: Up to 2 years
Conditional predictive models of imaging performance and agreement
Time frame: Up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer
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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.
Marta Crispens, MD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG), Positron Emission Tomography and Laboratory Biomarker Analysis in people with Stage IIIA Fallopian Tube Cancer and Stage IIIA Ovarian Cancer, run by Vanderbilt-Ingram 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 12 inclusion and 14 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 6 Jun 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Lesion (S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG) PET standard uptake values (time frame: Up to 2 years). The study lists 3 primary outcomes in all. 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 6 Jun 2018.