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68Ga-FF58 Imaging for Advanced Cancer

Q: What is the major focus of this investigation?

As reported by Novartis Pharmaceuticals, the research team's primary objective is to measure tissue time-activity curves from 68Ga-FF58 PET/CT images. Secondary outcomes include Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA), Terminal elimination half-life (T^1/2) of 68Ga-FF58 and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf).

Q: Is this research endeavor currently open to new participants?

According to the records on clinicaltrials.gov, this research is presently enrolling patients. The trial was initially listed on October 14th 2021 and subsequently updated November 30th 2022.

Q: What is the capacity for this medical study's patient participation?

Affirmative. According to the information posted on clinicaltrials.gov, this study is actively recruiting participants from October 14th 2021 and was last updated November 30th 2022. The trial is enrolling 80 subjects across a single site.

Phase < 1

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically or cytologically confirmed and documented r/r GBM that has progressed after prior radiation therapy and have not received prior bevacizumab

Patients with histologically or cytologically confirmed and documented locally advanced or metastatic GEA (i.e., adenocarcinoma of the stomach (intestinal subtype), esophagus, or gastroesophageal junction), either untreated or r/r after one or more lines of treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

Awards & highlights

Study Summary

This trialstudies a new imaging technique to diagnose and assess advanced cancer in adults.

Who is the study for?

This trial is for adults with certain relapsed or refractory solid tumors like glioblastoma, brain-metastasized breast cancer, gastroesophageal adenocarcinoma, or pancreatic cancer. Participants must have confirmed disease progression after treatment and meet specific health criteria such as adequate kidney function and no severe liver issues.Check my eligibility

What is being tested?

[68Ga]-FF58 is being tested in this first-in-human study to evaluate its imaging capabilities, safety profile, distribution within the body, and radiation dosage when used in patients with specific types of advanced cancers expected to overexpress αvβ3 and αvβ5 integrins.See study design

What are the potential side effects?

As a first-in-human study for [68Ga]-FF58, potential side effects are not fully known but may include reactions related to radiopharmaceuticals such as nausea or allergic responses. Close monitoring will occur due to the investigational nature of this compound.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My GBM has worsened after radiation and I haven't had bevacizumab.

Select...

My cancer is in the stomach, esophagus, or where they meet and is advanced.

Select...

My breast cancer has spread to my brain and there's at least one new brain tumor that hasn't been treated or has worsened after treatment.

Select...

My pancreatic cancer is advanced or has spread, and it may or may not have been treated before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (0, 0-5, 10, 30, 60, 120, 180-240, 300 minutes post infusion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Non-decay corrected tissue time-activity curves (TACs) from 68Ga-FF58 PET/CT images

Number of Participants with Lesions detected by [68Ga]-FF58 per Location

Number of lesions detected by [68Ga]-FF58

+2 more

Secondary outcome measures

Dosimetry Group: Absorbed dose of 68Ga- FF58

Dosimetry Group: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of 68Ga-FF58

Dosimetry Group: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of 68Ga-FF58

+10 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Pancreatic ductal adenocarcinomaExperimental Treatment1 Intervention

All eligible participants will receive recommended dose of [68Ga]FF58 of 3 Megabecquerel (MBq)/Kg (+/-10%) [but not more than 250 and not less than 150 MBq]

Group II: Glioblastoma MultiformeExperimental Treatment1 Intervention

All eligible participants will receive recommended dose of [68Ga]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].

Group III: Gastroesophageal adenocarcinomaExperimental Treatment1 Intervention

All eligible participants will receive recommended dose of [68Ga]FF58 of 3 Megabecquerel (MBq)/Kg (+/-10%) [but not more than 250 and not less than 150 MBq]

Group IV: Brain Metastasis from Breast CancerExperimental Treatment1 Intervention

All eligible participants will receive recommended dose of [68Ga]-FF58 of 3 Megabecquerel (MBq)/Kg (+/- 10%) [but not more than 250 and not less than 150 MBq].

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,857 Previous Clinical Trials

4,197,721 Total Patients Enrolled

Media Library

Gastroesophageal adenocarcinoma Clinical Trial Eligibility Overview. Trial Name: NCT04712721 — Phase < 1

Brain Tumor Research Study Groups: Gastroesophageal adenocarcinoma, Brain Metastasis from Breast Cancer, Pancreatic ductal adenocarcinoma, Glioblastoma Multiforme

Brain Tumor Clinical Trial 2023: Gastroesophageal adenocarcinoma Highlights & Side Effects. Trial Name: NCT04712721 — Phase < 1

Gastroesophageal adenocarcinoma 2023 Treatment Timeline for Medical Study. Trial Name: NCT04712721 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the major focus of this investigation?

"As reported by Novartis Pharmaceuticals, the research team's primary objective is to measure tissue time-activity curves from 68Ga-FF58 PET/CT images. Secondary outcomes include Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA), Terminal elimination half-life (T^1/2) of 68Ga-FF58 and Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf)."

Answered by AI

Is this research endeavor currently open to new participants?

"According to the records on clinicaltrials.gov, this research is presently enrolling patients. The trial was initially listed on October 14th 2021 and subsequently updated November 30th 2022."

Answered by AI

What is the capacity for this medical study's patient participation?

"Affirmative. According to the information posted on clinicaltrials.gov, this study is actively recruiting participants from October 14th 2021 and was last updated November 30th 2022. The trial is enrolling 80 subjects across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.

2021. "Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04712721.

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