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Could a Sugar-Like substance shrink tumors? new study explores High-Dose FDG for advanced cancer

NCT ID NCT02130492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests whether high doses of a radioactive sugar (FDG) can safely treat advanced cancers that no longer respond to standard therapies. FDG is taken up by cancer cells because they use a lot of glucose, and the radiation may kill them. The study involves 30 adults with stage IV solid tumors or lymphomas and monitors side effects and tumor shrinkage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2014

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Weill Medical College of Cornell University

    New York, New York, 10024, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.