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Advanced CancerPhase 1/2NCT02130492

A Pilot Study Treatment of Malignant Tumors Using [18F] Fluorodeoxyglucose (FDG)

A Phase 1/2 study testing FDG in people with Advanced Cancer, run by Weill Medical College of Cornell University at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

The objectives of this Pilot study are to investigate the toxicity and safety of high doses of [18F]-Fluorodeoxyglucose (FDG) used as a therapeutic agent in patients with advanced stage IV malignant tumors that failed standard of care treatment, have a good performance status and bear radiosensitive tumors with a high… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
FDG
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
May 2014to Jul 2028
Phase
Phase 1/2
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent.
  • Adults 21 years and older.
  • Stage IV solid cancers and stage IV lymphomas that failed to respond to two or more regimens of standard chemotherapy.
  • Life expectancy more than 3 months.
  • ECOG performance status equal to or less than 2.
  • Pathologically documented solid tumors and lymphoma.
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  • SUV in the primary tumor and/or at least one of the metastatic lesions will need to have an SUV ratio tumor to liver at least greater than 5 and the SUV in the bladder should not be above 100.
  • Adequate bone marrow, hepatic and renal function as evidenced by:
  • Liver function: bilirubin < 1.5x upper limit of normal (ULN) and SGOT (AST) < 2.5x ULN.
  • Renal function: Serum creatinine <1.5 times the ULN or creatinine clearance above 50.
  • Bone marrow function: WBC above 4,000/µl; platelet count above 100,000/mm3, absolute neutrophil count above 1,500/mm3, Hemoglobin above 10 g/dl.
  • Absence of brain metastases.
  • No patients under the age of 21 and no pregnant or nursing women will be enrolled. Women who are not of child bearing potential, and women of child bearing potential who agree to use, while on study, an effective form of contraception and who have a negative serum pregnancy test within 72 hours prior to initial study treatment. Two forms of approved contraception measures should be used simultaneously while on trial in premenopausal women.
  • Men willing to use, while on study, an effective form of contraception.
  • Ability to comply with all the aspects of the protocol and to come to the follow up visits as per protocol.

Who cannot join

  • Unacceptable uptakes to normal organs as determined after pre-enrollment PET imaging and serum and urinary dosimetry.
  • Patients with uncontrolled diabetes.
  • Patients with Stage IV lymphoma that involves the bone marrow or patients with solid tumors/ metastatic disease that involves more than 25 % of the bones.
  • Patients with radioresistant tumors (i.e. melanoma).
  • Patients with primary or metastatic disease to the marrow, heart or brain will be enrolled in order to prevent potential toxicity to these organs.
  • Patients with neurological disorders including strokes, seizure disorder, dizziness, vertigo, preexisting grade 2 or higher neuropathy, tremors.
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  • Mini Mental Test score less than 24.
  • Unexplained temperature > 101F or <95F for any 7 consecutive days or chronic diarrhea defined as > 3 stools/day persisting for 15 consecutive days, within the 30 days prior to treatment.
  • Prior chemotherapy or surgery within one month, or prior radiotherapy within 2 months.
  • Immunotherapy or biologic therapy within 1 month.
  • Radiation to more than 50% of the bone marrow.
  • Concurrent radiotherapy, chemotherapy. Post-menopausal women who are already using estrogens/progestins as hormone replacement therapy are permitted to enter and to continue using the hormones Tamoxifen and/or Aromatase Inhibitors will be accepted.
  • Significant cardiac disease (i.e. uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous year) or serious cardiac arrhythmia requiring medication.
  • Active acute infection or inflammation, as determined by increased wbc and fever or abnormal CXR. Inflammation in general can cause FDG uptake that may be severe enough to be confused with malignant lesions, especially when there is granulomatous inflammation such as tuberculosis, sarcoidosis, histoplasmosis, and aspergillosis among others and patients with inflammatory disorders are excluded.
  • Recent fractures within 2 months.
  • Psychiatric illness/social situations that may affect the patient's compliance with the treatment.
  • Current use of illicit drugs that may affect the patient's compliance with the treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Medical College of Cornell University

    New York, New York, 10024

Other trials in United States

About this study

The objectives of this Pilot study are to investigate the toxicity and safety of high doses of [18F]-Fluorodeoxyglucose (FDG) used as a therapeutic agent in patients with advanced stage IV malignant tumors that failed standard of care treatment, have a good performance status and bear radiosensitive tumors with a high [18F]-FDG uptake.

The investigators hypothesize that [18F]FDG may have a significant tumoricidal effect on cancer cells and radionuclide therapy of cancers with high doses of [18F]FDG administered as a single dose or in multiple doses (dose fractionation regimen) can be safe and well tolerated with minimal toxicities. Advantages of FDG are its uptake in many different human tumors, its short half-life (110 minutes) and the possibility to monitor its effect closely with the FDG-PET scan. The rationale for using high doses of this radiopharmaceutical agent for treatement is that most malignant lesions have accentuated glucose metabolism, which is mirrored by increased uptake of FDG. Since FDG cannot be metabolized within the cell like glucose, it is effectively confined within the cancer cells; thus, FDG treatment is potentially a novel form of targeted therapy for tumors with increased FDG uptake.

Read the detailed description

Photons, electrons and protons have therapeutic use however positrons have only been used for diagnostic imaging purposes.. The energies of positrons (β+) from F-18 (0.633 MeV) and electrons (β-) from I-131 (0.606 MeV) are very close and have similar equilibrium dose constants. Since [18F]- fluorodeoxyglucose (18F-FDG) clears rapidly from circulation, administration of 37-74 BGq (1-2 Ci) of 18F-FDG is relatively safe from an internal radiation dosimetry point of view. We initiated a phase I dose escalation study to assess the safety, toxicity, and potential therapeutic utility of administering high doses of 18F-FDG delivered over a 1 to 5 day period in patients with advanced lymphomas and solid tumors refractory to standard of care treatment (SCT). There will also be a Phase 2 portion of the study.

Conditions
Advanced Cancer
Being tested
FDG
Keywords
Stage IV cancers, Advanced lymphomas, Advanced sarcomas, Advanced solid tumors, Advanced cancers, Recurrent cancers, Hypermetabolic tumors
Medical subject headings
Neoplasms

What participants receive

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

  • FDGRadiation

    Also called [18F]-Fluorodeoxyglucose

    The intervention arm consists of treatment with increasing doses of [18F]-Fluorodeoxyglucose.

Study groups in NCT02130492
Study groupRoleWhat they receive
FDG armExperimentalPatients will receive increasing doses of FDG.
Receives: Radiation: FDG

What is being measured

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

  1. Number of Participants with Serious and Non-Serious Adverse Events and Type of Serious and Non-Serious Adverse Events

    Evaluate for any possible side effects related to the high doses FDG administered with therapeutic intent

    Measured: Up to 1 year post administration of FDG

Secondary outcomes (1)

  1. Efficacy Outcome Measure

    Tumor responses in terms of size (CT scans) or FDG uptake (FDG-PET scans) will be carefully recorded and monitored using RECIST Criteria.

    Measured: Up to one year post FDG treatment

Timeline

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

  1. First posted5 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Why it stopped: Temporarily interrupted due to lack of funding: will re-open in the near future

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02130492
Sponsor's protocol ID
IRB# 13-382A
Status last verified
May 2026
First submitted
1 May 2014
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Paul DM, Ghiuzeli CM, Rini J, Palestro CJ, Fung EK, Ghali M, Ben-Levi E, Prideaux A, Vallabhajosula S, Popa EC. A pilot study treatment of malignant tumors using low-dose 18F-fluorodeoxyglucose (18F-FDG). Am J Nucl Med Mol Imaging. 2020 Dec 15;10(6):334-341. eCollection 2020.

    PubMed 33329935

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FDG in people with Advanced Cancer, run by Weill Medical College of Cornell University 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 15 inclusion and 17 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: paused, as of the sponsor's last update on 15 May 2026. 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?

Results are not available in the source record.

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?

Number of Participants with Serious and Non-Serious Adverse Events and Type of Serious and Non-Serious Adverse Events (time frame: Up to 1 year post administration of FDG). 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 NCT02130492, 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 15 May 2026.

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